Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed.
the mhra has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. no instruction was provided on how to check the condition of the mattress and cover. this presents a risk of cross infection.
the manufacturer has omitted to provide customers with information on how to undertake suitable checks and decontamination procedures. the manufacturer does not include full decontamination details with the instructions for use, due to different requirements in different countries. in the uk they are covered in a separate document, w13001uks rev2.
two nhs trusts have reported a risk of cross infection with this bed. residues of body fluids from previous occupants have been found under mattress covers.
many of these beds are used by intensive care units.
the mhra has not received any adverse incident reports of cross infection occurring due to this problem.
Acción
Trace all Hill-Rom TotalCare Duo 2 beds in use and in storage.
Contact Hill-Rom on 01530 562167 for copies of the cleaning and disinfection instructions.
Unzip the mattress covers and check for signs of fluid contamination on the mattress and damage or holes in the mattress covers.
Dispose of damaged covers. If replacement or spare mattresses and mattress covers are required, contact Hill-Rom on 01530 411000
Between each patient use check whether any fluids have penetrated the cover and follow Hill-Rom’s cleaning, disinfection and laundry advice for the covers and mattresses.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Potential for inaccurate display of:
battery voltage
expected battery longevity
elective replacement indicator (eri) status
at initial programmer interrogation.
st jude medical has advised mhra that a programmer software anomaly can occur when the above programmers and pacemakers are used together. the manufacturer notified their uk customers of this issue in a letter dated 12 october 2006 (see appendix).
the problem, which has only affected 53 out of approximately 199,100 pacemakers, results in the display of inaccurate battery voltage, expected battery longevity, and eri status. the anomaly does not affect the pacemaker's actual battery voltage, longevity or functionality. display of inaccurate data
only occurs at initial programmer interrogation.
correct battery voltage measurements and longevity status etc. will only be displayed when a
manual measured data reading is performed.
the anomaly is the result of a software interaction where a memory location within the pacemaker changes state. when this occurs, the data read on initial interrogation (from the pacemaker's memory) is not up to date. this affects the calculations for battery voltage, remaining longevity, eri status and magnet rate and therefore the displayed information is incorrect. in addition, as pacemakers approach the elective replacement time, this could result in the reporting of inappropriately high battery voltage and remaining longevity and could result in a delay in indicating eri status.
to correct this problem, st jude medical has developed a software upgrade which, when installed on the programmer, will automatically correct an affected pacemaker memory location and ensure accurate battery status information is displayed. st jude medical advises that this will take place on first pacemaker interrogation following programmer software upgrade and will not extend the time needed for the appointment. st jude medical plans to release the upgraded software in december 2006 and anticipates that all potentially affected programmers in the uk will receive the software upgrade by the end of january 2007.
st jude medical has already communicated this information to all uk hospitals that have received potentially affected pacemakers and programmers. neither st jude medical nor mhra have received any reports of adverse clinical events associated with this issue.
Acción
See detailed actions for patient management on page 3.
For patients with pacemakers within two years of the longevity published in the pacemaker manual, perform a patient follow-up as soon as practically possible, giving priority to pacing dependent patients.
For patients with pacemakers not within two years of published longevity, perform follow-up at the scheduled intervals.
If you already routinely perform a manual measured data reading during follow-up, there is no need for any action.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Health canada (the canadian regulatory authority for medical devices) has suspended sale of these kits in canada due to concerns about the manufacturer’s quality systems – see:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.Php
health canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device.
the mhra has not received any reports of adverse incidents in the uk involving these devices.
the product is currently still available for use in the uk
the mhra is continuing to monitor this situation.
Acción
Users should report any incidents of false results involving these products to the MHRA and the supplier, to enable the MHRA to monitor the situation in the UK.
Note: the MHRA will consider the need to issue further advice based upon information received from UK users.
Healthcare personnel treating patients based on results from test strips.
Healthcare personnel using, supplying, supervising, quality assuring or distributing these test strips.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
MHRA is aware that some users of the FreeStyle Libre flash glucose monitoring system are applying barrier creams, patches and sprays before attaching the sensor to reduce skin reactions. These barrier methods have not been tested by the manufacturer and may therefore affect the performance of the device.The severity of the skin reaction can vary from person to person and for certain users this is a skin hypersensitivity reaction rather than an irritation reaction. For this type of reaction, once the person has become sensitised to the adhesive, every time the sensor is reapplied a skin reaction will occur. With each reapplication, the symptoms might appear more quickly and may worsen.The manufacturer has confirmed that they have revised the formulation of the adhesive, which will be available to UK customers from April 2019.Please note this problem may not be unique to the Abbott FreeStyle Libre sensor adhesive.
The same actions should be taken if patients experience similar symptoms with a different brand of continuous glucose monitoring system.
Causa
Manufactured by abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
Acción
Identify patients who have reported or may be experiencing skin reactions, which may include erythema, itching and blistering.
Consider if continued use of this device for patients with skin reactions is suitable.
Consider use of alternative glucose monitoring systems for these patients.This is consistent with the guidance already provided in the manufacturer’s instructions for use, which state:Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre system. Contact your health care professional before continuing to use the FreeStyle Libre system.Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by arjohuntleigh ab – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
Acción
Check which version of the spreader bar your lifts have, using the manufacturer’s instructions in their Field Safety Notice (FSN).If your device requires replacement, please stop using it immediately, quarantine it and contact Arjo UK.If your device does not need replacement, fill in and return the customer response form in the FSN to Arjo UK to confirm this.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by acutronic medical systems ag – ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
Acción
Identify all affected ventilators – see the Problem section of this alert or the manufacturer’s Field Safety Notices (FSNs) reference FSCA 18-003 and FSCA 18-004.
Use an alternative ventilator for treatment if available.
If no alternative is available, carry out – and document – a risk assessment based on a clinical risk-benefit analysis before using the ventilator.
If you continue to use an affected ventilator, make sure you follow the instructions in the manufacturer’s FSNs and be extra vigilant.
Disconnect any ethernet connections from the device.
All affected ventilators that have unexpectedly shut down or had power cycling should be removed from service.
Complete the End User Response form(s) and return to Kevin.Nash@inspiration-healthcare.com. If you are affected by both FSNs, you must return both forms.
Report any incidents or complaints involving this product to info@acutronic-medical.ch
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Following withdrawal of the CE mark for the Aquilon series of nebulisers, the manufacturer (AFP Medical) has continued to place the nebulisers on the market.The nebuliser and packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
Causa
Manufactured by afp medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (mda/2018/008).
Acción
Identify affected devices from the list below.
Identify patients and relevant healthcare professionals and advise them to:
stop using and dispose of the nebulisers
use an alternative nebuliser where available
Patients who have any concerns should contact their GP or other healthcare professionalAction by:All medical, nursing and technical staff involved in the use and maintenance of these devices.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by alere – point-of-care tests for use only in professional clinical settings: specific lots are affected.
Acción
Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN).
Where affected devices have been used, ensure that initially reactive p24 antigen and/or antibody results that were obtained from EDTA whole blood samples are retested using another method.
Ensure the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made.
Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN). and that they understand the problem and to check that the actions have been taken.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Inratio® and inratio®2 pt/inr coagulation monitor and test strips used at home and at point of care. manufactured by alere.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
The APC Medical E4162, E4164, E4165 and E4166 external pacemaker models incorporate a design feature whereby the pacing rate will increase by approximately 20ppm, when either the battery voltage becomes low, or when electromagnetic interference is sensed. In both instances the mode of pacing changes from demand to asynchronous pacing. The original intention of this design feature was to avoid competitive pacing and pacing on the T-wave (initiating VT/VF), by increasing the set paced rate by approximately 20ppm.Some patients however may not tolerate such a sudden increase in pacing rate, which may be detrimental to their condition (eg open-heart surgery, valve replacement, congestive heart failure, myocardial infarction, arrhythmia etc). MDA became aware of an incident involving one of the above devices, where the design feature initiated an unexpected change in pacing therapy, which could be inappropriate for certain patients. In the device concerned, failure analysis determined an internal component failure in the battery monitoring circuit. This resulted in inaccurate detection of the battery voltage, which was incorrectly sensed as low. This initiated asynchronous pacing and an increase in pacing rate by an additional 20ppm. The clinician concerned was unaware of the device feature.The APC Medical E4162, E4164, E4165 and E416 pacemakers were designed and manufactured over 20 years ago and therefore clinicians may not be familiar with all the instructions for use, which may not be readily accessible. The design feature common to the above models is not widely used in modern external pacemakers, which incorporate different warning systems to alert users to low battery voltage or the presence of electromagnetic interference.MDA has previously advised that some external pacemakers (including APC model E4162) are susceptible to interference from mobile communications systems 1,2,3 and care should be taken to ensure that patients supported via external pacemakers are not exposed to electromagnetic fields from mobile phones, walkie-talkies etc. MDA has also previously advised that older external pacemaker models should be withdrawn and replaced. 4,5 APC Medical advises that E4162, E4164, E4165 and E416 models have a 15-year service life expectancy and recommends their replacement at the end of that period.Consideration should therefore be given to replacing the above models as soon as practicable. Risk managers are reminded of the Controls Assurance Standard - Medical Devices Management (Criterion 18)6, which addresses the replacement of medical devices in detail, extract as follows:For both hospital and community devices, a stage is reached at which replacement must be considered. If any of the following seven criteria apply, the device is no longer serviceable:Worn out beyond economic repair
Damages beyond economic repair
Unreliable (check service history)
Clinically or technically obsolete
Spare parts no longer available
More cost-effective or clinically effective devices have become available
Unable to be cleaned effectively prior to disinfection and/or sterilisation”
Causa
(apc medical ltd) the pacing rate for models e4162, e4164, e4165 and e4166 may increase by 20 pulses per minute and change in pacing mode in some cases. (mda/2003/008).
Acción
Be aware that the above external pacemakers will revert to asynchronous mode pacing at a rate of approximately 20 ppm above the pre-set pacing rate, when either the battery voltage is low or electromagnetic interference is sensed.
Ensure that the above devices are not used for patients where a sudden increase in paced rate of 20 ppm, or a change from demand to asynchronous mode pacing, could compromise patient health.
Consider replacing the above pacemaker models (which were designed and manufactured over 20 years ago) as soon as practicable.
When the above external pacemakers are used, ensure also that mobile communication devices are not used in the vicinity, especially during patient transfer.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
The Food and Drug Administration (FDA), the USA regulator, has identified problems with quality management systems at Maquet and their subsidiaries (including Atrium Medical). Further information can be found on the FDA website. A consent decree has been issued, which prevents one of the USA-based sites from distributing devices.The FDA’s consent decree requires that Atrium Medical’s (Maquet) customers sign a Certificate of Medical Necessity to allow the company to continue the supply of medical devices listed above.The status of other medical devices sold by Atrium Medical (Maquet) is available in Atrium Medical’s Notification Guide.Although the devices listed in the consent decree are CE marked and can be legally sold in the UK, you may be asked to sign a Certificate of Medical Necessity by the manufacturer.
Causa
(atrium medical subsidiary of maquet) guidance for healthcare professionals who have received a food and drug administration (fda) consent decree from maquet about its subsidiary atrium medical. (mda/2015/006).
Acción
You should:be aware that Atrium Medical (Maquet) is likely to contact you about the consent decree before you can purchase further devices
review the medical need for continued use of the devices listed in the consent decree including the availability of suitable alternatives
if you need to purchase further devices, sign the Certificate of Medical Necessity and return to Maquet
be aware that a Certificate of Medical Necessity is not required for existing hospital stock
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.The MHRA is aware of reports of patient deaths (including four in the UK) associated with the use of the SILK device. These fatalities occurred between 5 and 150 days after implantation.The causes of these deaths have not been conclusively determined. However, each of these patients had been treated for an existing large (15 to 25mm) or giant (25 to 50mm) intracranial aneurysm and without the use of additional embolisation coils.The manufacturer (Balt Extrusion, France) issued an urgent Field Safety Notice on 09 March 2010 advising that it does not currently have the clinical data to support the use of the SILK device without the use of embolisation coils.The manufacturer now intends to amend the instructions for use (IFU) to reflect this advice. It is also planning a post-market clinical trial to investigate the use of the SILK device without coils in aneurysms with a diameter less than 15mm.
Causa
(balt extrusion) potential for patient death if you use any silk artery reconstruction device to treat intracranial aneurysms without embolisation coils. (mda/2010/023).
Acción
Do not use the SILK device without embolisation coils.Identify patients who have been implanted with the SILK device without embolisation coils and:assess the status of the aneurysm at approximately 3 months post implant by a non-invasive technique eg CTA/MRA
assess the status of the aneurysm at approximately 6 months post implant by an invasive technique eg angiography
insert a further stent if the aneurysm status is unsatisfactory at these times.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
Acción
Identify affected devices.
Ensure that:
users understand the problem detailed in the Field Safety Notice and follow the manufacturer’s advice
Have systems in place to ensure the upgrade is undertaken as soon as possible or at least by the next planned annual maintenance service. Baxter will contact users to schedule the software upgrade of your devices to rectify the issue.
Return the Field Safety Notice acknowledgement form to Baxter as currently the manufacturer hasn’t received enough responses.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
The povidone-iodine contained in the disconnect caps of these peritoneal dialysis sets has the potential to be a contributing factor to thyroid changes such as hypothyroidism. Patients more likely to be affected are infants and children with smaller peritoneal fill volumes, where higher dialysate concentrations of iodine can result.
Causa
(baxter healthcare ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (mda/2006/022).
Acción
The thyroid function should be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. In order to minimise iodine exposure, the contents of the peritoneal cavity should be drained to the drain receptacle prior to the initiation of the next fill cycle whenever clinically possible.Users should be aware of the advice in Baxter’s Safety Alert (see appendix in pdf).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by baxter healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Bd alaris/asena syringe pumps (specific product codes) – internal malfunction may cause pl3 alarm to sound and the infusion to stop (mda/2017/036).
Acción
Identify all devices with product codes listed in the Field Safety Notice (FSN).
Stop using any pump that exhibits a PL3 alarm
If you have any pumps manufactured before 2008, contact BD Carefusion to arrange for repair as detailed in the technical service manual
Comply with recommended preventative maintenance processes as defined in the technical service manual
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by becton dickinson (bd) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
Acción
Identify all lots of syringes that have an expiry date up to and including April 2021.
Ensure all users are aware of the manufacturer’s Field Safety Notice published in February 2017.
Contact the manufacturer to acknowledge the FSN and arrange to return affected syringes for replacement.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
BD have published a Field Safety Notice to advise users to discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology.BD have identified that Thiuram, a chemical in the rubber tube stopper may release sulfur gases which bind to the lead particles in the blood sample making it difficult to detect the correct amount of lead in the sample and may give false low results when using ASV methodology, used in Magellan Diagnostics’ LeadCare® Testing Systems, and other assays.BD have undertaken a programme of testing to identify if any other assays are affected by the issue identified. To date no other assays have been noted to be affected. Revised instructions for use will be made available for users to download by the 8th May 2018.
Causa
Manufactured by becton dickinson (bd) – due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using anodic stripping voltammetry (asv) methodology.
Acción
Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN).
Discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology. There is no requirement for customers to return affected devices to BD.
Review previous lead test results which were performed using Magellan LeadCare® instrumentation or any other assay employing ASV methodology.
Lead testing using Graphite furnace atomic absorption spectroscopy (GFAAS) coupled with ICP-MS are not affected by this issue and can be performed as normal with BD Vacutainer® EDTA and BD Vacutainer® Lithium Heparin tubes.
If any adverse events occur relating to these products, please report these to MHRA via YellowCard or the relevant devolved administrations (Scotland, Wales and Northern Ireland).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
If moisture gets into the damaged test card pouches, it can stop the antibiotics working properly.The manufacturer’s investigation found that the root cause of the problem was a combination of stitch
seal wheel design/positioning on the manufacturing equipment, and product shipping/handling. The stitch seal wheels on the manufacturing equipment have now been replaced with a new design.
Causa
Manufactured by biomérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.
Acción
Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice and that they understand the problem and the actions to be taken.
Destroy any defective cards
Contact Biomerieux to acknowledge receipt of the Field Safety Notice (dated 20 April 2017) even if you don’t have affected devices left in stock.
Consider the need to repeat test if you observe any of the following results from the affected lots:
a resistant imipenem result, particularly if unexpected and/or inconsistent with other results
a resistant or intermediate nitrofurantoin result which is unusual or inconsistent with other results
a resistant oxacillin or erythromycin result which is unusual or inconsistent with other results
any quality control test result with these agents that is outside of the expected range
If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used
As part of your review processes, report any incorrect results to MHRA
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
In December 2016, Zimmer Biomet issued an FSN informing clinicians of the higher than anticipated rate of fracture of titanium Comprehensive Reverse Shoulder Humeral Trays manufactured prior to September 2011. The affected products were distributed between September 2010 and January 2017.The mean time to fracture is approximately 3 years. The clinical symptoms of device failure include pain, swelling, loss of function and dislocation of the shoulder prosthesis.MHRA is issuing this alert to ensure that clinicians are aware of this issue and consider appropriate follow-up of patients implanted with affected devices.
Causa
Manufactured by zimmer biomet - recall due to increased risk of fracture for all titanium trays manufactured before september 2011 and distributed in the uk between september 2010 and january 2017.
Acción
Do not implant Comprehensive Reverse Shoulder Humeral trays from the lots listed in the manufacturer’s field safety notice (FSN)
Locate and return all affected products to Zimmer Biomet
Identify all patients implanted with the affected device and inform them of this issue
Advise patients to contact their orthopaedic surgeon if they develop symptoms such as pain, swelling, dislocation or a change in shoulder shape or function
Symptomatic patients should be investigated, which may include imaging such as x-ray to identify a possible fracture of the device
Report all adverse events involving the Comprehensive Reverse Shoulder humeral tray to Zimmer Biomet and to MHRA or the appropriate Devolved AdministrationsIn all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of the Ionising Radiation (Medical Exposure) Regulations 2000.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
In December 2017 Biomet issued a Field Safety Notice informing healthcare professionals that the mechanical strength of the affected batches of bone cement may be reduced increasing the risk of revision. There is also a risk of prolonged surgery from increased polymerisation time when using affected batches of bone cement. The manufacturer suggests it would be prudent to monitor closely affected patients as part of their standard follow-up.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
Causa
Manufactured by biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
Acción
Identify and quarantine all affected devices. (See table below for affected batches.)
Follow actions recommended in the manufacturer’s Field Safety Notice.
If at time of use the setting time was longer than indicated in the manufacturer’s instructions for use these patients may require more frequent follow up.
For all affected patients, surgeons will need to formulate a local risk assessment and follow-up plan based upon the length of time the device was in storage and relevant patient variables. The affected batches are known to have their mechanical strength reduced by half after 6 months in storage.
Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Delay in delivery of therapy during device middle-of-life phase due to temporarily extended charge time limits.
Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available.The MHRA has received 31 reports of early explants from four of the above device models (1870, 1871, 1872, A135) during the middle-of-life (MOL) phase. Replacement has been due to observation of premature elective replacement / end of life indicators (ERI/EOL), caused by long capacitor charge times. The MHRA has also become aware of confusion about ERI/EOL indicators throughout implant duration.Incident reports have included devices displaying:extended charge times where no replacement / end of life indicators have been observed
ERI where charge times have extended beyond 26 seconds giving rise to potentially inappropriate therapy delay for some patients
EOL indicators with charge times in excess of 30 seconds without ERI being observed in the first instance.Boston Scientific ICDs / CRTDs are designed to regularly monitor both battery voltage and capacitor charge time, and flag ERI when specified limits are exceeded. Charge time ERI is flagged whenever two charges (capacitor reform or therapeutic shock) occur within a 24hr period in which both exceed the specified limit.Increase in charge time (due to a rise in battery impedance) is an expected behaviour of ICDs that have lithium-silver-vanadium-oxide batteries. However, early batteries used in some of the above models have a tendency to exhibit a more exaggerated increase in battery impedance during the MOL phase, due to a battery manufacturing anomaly.Boston Scientific has confirmed that the above models have been programmed with temporarily extended ERI charge time limits during the MOL phase (compared to unaffected models). This is to prevent premature tripping of ERI due to the battery impedance characteristic.In January 2007, Boston Scientific issued a product update about this issue via their website. The company issued a more detailed and informative product update about this problem in March 2007.The MHRA is issuing this Medical Device Alert to ensure that all UK clinicians who implant these devices, or manage patients already implanted with these devices, are aware of Boston Scientific’s communication and can therefore consider the clinical implications of long charge times that may be inappropriate for some patients.
Causa
(boston scientific ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. (mda/2007/023).
Acción
Identify patients implanted with these devices, asses clinical risks associated with the above device problems, and follow the actions on page 2.Be aware of:
extended capacitor charge times during device MOL phase, as documented in the most recent Boston Scientific product update (see the MHRA’s website for March 2007 issue)
the higher prevalence of long charge times in earlier manufactured devices (see Appendix 2 below)
the potential for earlier manufactured devices to pass from ERI to EOL in less than three months.
At the next scheduled follow-up, review capacitor charge time history and evaluate the appropriateness of charge time according to patient condition and device dependency, giving priority to those who have not been followed up within the last three months (see Appendix 1 below).
Consider the risks (infection etc) and benefits of elective device replacement where capacitor charge time is judged to be inappropriate for an individual patient.
Consider scheduling future patient follow-ups at three monthly intervals – where the device is around MOL, to increase the likelihood of detecting longer charge times, early ERI and/or EOL as appropriate.
Consider programming the ‘Beep When ERI is Reached’ feature to ‘ON’ (default) for all affected patients.
Remind patients to contact their follow-up centre immediately if they hear beeping from their device and/or experience arrhythmias/resumption of symptoms that remain uncorrected by the device.
Consult the Boston Scientific website for future related product updates.
Report all instances of device failure to the MHRA and Boston Scientific.
Report explants to the National Pacing and ICD Database (see contacts on page 3).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Boston Scientific issued an FSN on the 19 December 2017, following reports of pacing inhibition due to oversensing of the MV sensor signal. Note that the nominal setting for MV sensor in affected Boston Scientific pacemakers is “Passive”, which presents the same patient risk of oversensing as when it is reprogrammed to “ON”.There are approximately 32,500 affected patients at 308 centres in the UK. To date there have been 184 reported oversensing events worldwide (22 in the UK) representing 0.05% of sales of these device models. These include 31 known incidents of serious injury or death (8 in the UK) including patient dizziness, syncope or falls. The true prevalence of the MV oversensing is, however, unknown as it can go undetected if the patient remains asymptomatic.Intermittency related to the lead or pacemaker-lead connection can lead to transient high impedance conditions, which can alter the MV sensor signal which can become visible on an electrogram and potentially cause oversensing on the right atrial or right ventricular channels. Further information is provided in the FSN.Based upon data from reported events, and testing of competitors’ leads, Boston Scientific has indicated that the issue tends to be more prevalent in leads with greater terminal ring motion within the pacemaker header such as Medtronic or Abbott leads. Boston Scientific has also indicated that over 60% of MV oversensing reports have involved their devices connected to Medtronic or Abbott leads, despite only around 12% of the affected models being implanted with these competitors leads (based on US data).A software fix mitigating the risk of MV oversensing is currently being developed by the manufacturer and is planned to be released by October 2018. In the meantime, an accelerometer based rate response function can be programmed for these pacemakers where deemed clinically necessary. Further information is available from Boston Scientific.Note that some patients affected by this MV field action may also be affected by a second FSN issued simultaneously by Boston Scientific on left ventricular offset interaction, which provides separate patient management recommendations not covered by this MHRA alert.
Causa
Manufactured by boston scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (mda/2018/001).
Acción
Read the manufacturer’s Field Safety Notice (FSN)
Identify all patients implanted with the affected devices listed below.
Schedule a follow-up of pacemaker-dependent patients as soon as possible, within 6 weeks, with priority to those with pacemakers connected to competitors’ pacing leads (see Problem/background). This should include reassessment of patients whose current degree of pacemaker-dependency is uncertain. Turn off the minute ventilation (MV) sensor for all pacemaker-dependent patients.
Evaluate the risks of pacing inhibition against the benefits of MV based rate adaptive pacing (and other MV based diagnostic functions) within 6 months for patients not considered to be pacemaker-dependent. Prioritise those with pacemakers connected to competitors’ pacing leads (see Problem/background).
Consider the following for patients left with the MV sensor “ON”:
* monitoring for signs of MV oversensing, such as transient, abrupt changes or out-of-range RA/RV pacing impedance measurements, or MV sensor signal artefacts on ECGs.
* increasing the frequency of patient follow-ups to assess for future pacemaker dependency.
Adopt increased vigilance and report any suspected incidents to the MHRA and Boston Scientific
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
For devices implanted subpectorally there are risks of:loss of shock therapy
inappropriate shock therapy
loss of pacing therapy
loss of anti-tachycardia pacingThe manufacturer has established that the bond between the header and case of these specific models can be weakened either from significant forces associated with a subpectoral implant procedure or when a device in a subpectoral position is repeatedly pushed against a rib during contraction of the pectoralis muscle.The following factors may have an impact on the risk of failure if affected devices are implanted subpectorally:exact location of the patient’s ribs relative to the device
body size and/or muscle mass of the patient (risk increases for larger or muscular patients)
activity level and/or occupation of the patient (risk increases for more active patients)
increased implantation duration.The manufacturer issued a Field Safety Notice in December 2009 informing clinicians about this issue.
The manufacturer has confirmed that approximately 2,500 affected Teligen and Cognis devices have been distributed on the UK market since these models were released in June 2008. They have estimated that approximately 5% of affected devices are implanted subpectorally worldwide. Devices implanted subcutaneously are not included in this advisory.To date the manufacturer has confirmed two (non-UK) reports of device malfunction associated with this issue out of approximately 77,000 devices sold worldwide. Both devices required early replacement (at four and five months post-implant) as they had delivered inappropriate shocks. The manufacturer has not identified a mean time-to-failure for this problem.
Causa
(boston scientific) specific models of defibrillators implanted subpectorally have a risk of loss of shock therapy, inappropriate shock therapy, loss of pacing therapy or loss of anti-tachycardia pacing. (mda/2010/012).
Acción
Review records to identify patients with an affected device implanted subpectorally.
Recall affected patients for baseline measurements within six weeks, giving priority to those who are pacing-dependent or who have not been followed up within the previous three months.
Consider programming ‘Daily Measurement Alerts’ for lead impedance to ‘On’.
Consider prophylactic replacement of affected devices in high risk patients.
Remind affected patients to contact their clinic if they receive shocks.
Follow up affected patients at three-month intervals (as stated in the manufacturer’s instructions for use).
Avoid subpectoral implantation of these models.
Report device failures and adverse incidents to Boston Scientific and the MHRA.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013.In August 2013 Boston Scientific notified users about a subset of COGNIS™ CRT-Ds and TELIGEN™ ICDs that had experienced an increased rate of premature battery depletion due to a problem with a low voltage (LV) capacitor. The manufacturer has now identified a second subset of devices from subsequent clinical experience and analysis, which is expected to be affected by the same capacitor issue. This adds an additional 885 UK patients to the previous total of approximately 1,000 UK patients identified in August 2013.With this FSN the manufacturer has also notified pacing clinics about the recent introduction of updated Safety Architecture software that will improve early detection of diminished LV capacitor performance. In particular this software enhances detection rates for ICDs later in their device life, and provides a new alert indicator on the programmer screen and the LATITUDETM remote patient monitoring system (if used).The manufacturer has confirmed that the current prevalence of failures within the original advisory population has risen from 0.67% in August 2013 to 2% to date, with the newly identified devices expected to perform similarly. The latest FSN provides important additional information on cumulative survival rates* for devices both within and outside the advisory subset population to help with future patient management.*United States data, correct up to 21 July 2014
Causa
(boston scientific) rapid battery depletion leads to risk of loss of therapy. (mda/2014/039).
Acción
Identify newly affected patients according to Boston Scientific’s latest Field Safety Notice or look-up tool and schedule them for an in-clinic visit as soon as possible (within 3 months at the latest).
Interrogate the device using a programmer which has received the new software provided by Boston Scientific. This will automatically download improved software for detecting a failing capacitor.
If a ‘Code 1003’ alert is seen on the programmer screen, contact Boston Scientific Technical Services to help clarify the time to ‘End Of Life’ (EOL) of the device. Note that ‘Approximate time to Explant’ and ‘Time Remaining’ estimates displayed on the programmer are not accurate when this capacitor malfunction has occurred.
Schedule device replacement taking into account time to EOL prediction provided by Boston Scientific.
Ensure that all audible alerts have been programmed ‘ON’ and remind patients to contact their clinics immediately if they hear beeping.
Consider the benefits of monitoring patients at home using the LATITUDE™ Patient Monitoring System.
Schedule patients already identified by MDA/2013/072 for follow-up within 3 months to download their ICDs with the improved software for detecting a failing capacitor.
This notice replaces MDA/2013/072 issued in September 2013.Note:
Prophylactic replacement of these devices is not recommended