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
Risk of under- or over-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia, with a consequent loss of consciousness or death, in extreme cases.
the root causes are:
spillage from the insulin reservoir may block connector vents, preventing correct priming of the pump. medtronic have issued advice on the correct technique for filling the reservoir.
the insulin reservoir may leak, due to a manufacturing defect, which may result in under delivery of insulin and failure of the pump’s occlusion alarm. medtronic have initiated a recall of affected reservoirs.
Acción
Identify affected infusion sets and reservoirs.
Ensure that all relevant staff and patients receive the appropriate copy of Medtronic’s Field Safety Notices and are aware of the recommendations. In particular:
Ensure staff and patients follow the manufacturer’s recommendations to avoid spillage from the insulin reservoir.
Discard unused, affected reservoirs immediately and request replacements.
Return Field safety Action sheet to 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
Causa
Kent and ascot baths with a transfer seat and shepherd’s crook / shower pole fitted. manufactured by care in bathing ltd.
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
Risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.
capatex is recalling affected products and has advised users of the issue in field safety notices (see appendix). this medical device alert is being issued to reinforce the manufacturer’s actions.
a change was made to the composition of the plastic material used, to make the clamps/holder dehp-free. this affected the physical properties of the clamps, resulting in an increased risk of slippage. to counteract this, capatex added an extra notch on the clamp. however, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube.
all clamps from lot number 1002854 onwards have been manufactured using a new material.
Acción
Identify affected devices and quarantine them.
Contact Capatex to arrange for devices to be exchanged or to confirm that you have none in stock.
Follow the advice in the FSN dated February 2012 (see appendix). In particular, follow advice on Capatex clamp/holder size and corresponding size of endotracheal tube to be used.
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
On specific batches of model 404 walking sticks the handle can crack and may cause the user to fall.
patterson medical ltd issued a field safety notice in june 2013 but has had insufficient confirmation from users that they have acted on this information.
Acción
Identify and remove all affected batches of walking sticks from use.
Safely dispose of all affected walking sticks - contact Patterson Medical Ltd. for advice.
Complete and return the reply letter to Patterson Medical Ltd, if not already completed.
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
Counterfeit ultrasound transducers have been supplied to 2 hospitals.
these devices may not meet the performance specified by toshiba. there have been no reports of patient harm.
transducers supplied directly by toshiba medical systems uk are not affected.
mhra and toshiba will continue to investigate this matter as new cases appear.
the mhra has become aware that counterfeit toshiba ultrasound transducers have been found in two hospitals in the uk.
as there is no evidence of patient harm, mhra is not recommending that patients are called back to their hospital or clinic. we are publishing this alert as a precautionary measure to raise awareness of the issue and to ask users to check toshiba ultrasound transducers not supplied direct from toshiba medical systems uk.
as counterfeits may look very similar to legitimate products, they need to be checked very carefully. however, a competent user should easily identify a fake transducer. in addition, the device should have undergone quality checks before being brought into use. these devices are also subject to periodic quality and maintenance checks.
there is guidance for healthcare providers from ipem, sor and cqc on the procurement, initial acceptance testing, quality assurance and maintenance of these devices. this would mean that counterfeits should be identified before use.
Acción
Identify and quarantine any suspect devices. Further advice on how to identify fake devices is given on pages 2 and 3 of this alert.
To authenticate suspected devices, contact your local Toshiba representative via their dedicated email report.counterfeit.uk@tmse.nl
Report any counterfeit devices to the MHRA via Yellow Card
Counterfeit transducers can be identified by one or more of the following characteristics:
The label may be poorly attached and made of paper. It may also peel off easily and leave a residue. Toshiba labels are plastic or metal and are difficult to remove
The descriptive text may be incorrect – a linear transducer array may be described as ‘convex’
Since 2005 Toshiba serial numbers are ten digits long e.g. TDA1293472. Any label with fewer numbers is likely to be counterfeit
Scanning the QR code (if any) on the label will not take the user to a website or it gives a different probe type and serial number
The Toshiba logo or wording may not be as sharp, and the casing may have a different finish when compared to a genuine probe
Counterfeit Toshiba transducer heads can be substantially lighter in weight than genuine Toshiba items
The pictures below are examples only to help identify suspected counterfeit probes.
They do not represent all possible fake 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
Affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration.
the manufacturer distributed the affected lots in the uk via wholesale outlets during october and november 2012. the product may, however, still remain with users or pharmacies.
there is currently no evidence that uk patients have been affected.
Acción
Identify and quarantine affected lots.
Identify patients using these meters and advise them that they should return and not use strips from the affected lots.
Ensure that users who return strips from the affected lots can continue to monitor their blood glucose.
Contact Menarini to arrange the return of any strips from the affected lots.
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.
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
A small number of multi-reagent cassettes in affected lots have been found with labels containing product information on the wrong side of the cassette.
the use of affected multi-reagent cassettes may lead to false negative or false positive results, causing a potential misclassification of the patient or donor blood groups or rh/k phenotypes or incorrect antibody detection results. this may be of particular clinical concern where there is no confirmation of the group (e.G. in testing of newborns or where reverse grouping is not in place).
ortho clinical diagnostics have sent out a field safety notice having identified the cause of the manufacturing issue.
Acción
Do not use and quarantine products from affected lots received prior to 5 July 2013. Contact the manufacturer urgently for replacement product.
Products from affected lots received prior to 5 July 2013 should be used only where no alternative stock is available and must be inspected prior to use (see manufacturer’s Field Safety Notice).
Discard products from affected lots received prior to 5 July 2013 once replacement stock is available for use.
Consider the need to review patient results from the affected lots.
As part of your look back process, report any incorrect results to the MHRA and Ortho Clinical Diagnostics.
Directors of pathology
Lead clinical scientists (haematology)
Lead biomedical scientists (haematology and blood transfusion)
Clinical services managers
Laboratory managers
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
Testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation.
the tianjie dental falcon is not ce-marked as a medical device.
Acción
Identify and stop using this and similar non CE-marked devices.
Replace the device with a suitable CE-marked alternative.
Be aware of the NRPB (HPA) Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment or the Medical & Dental Guidance Notes published by IPEM.
Be aware of the general requirement to consult a suitable radiation protection adviser with regard to the use of X-ray equipment.
Be aware of MHRA advice on the use of non-CE marked devices.
Report any suspected devices to MHRA Adverse Incident Centre.
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
Risk of leakage or air embolism due to hub cracking at the female luer connector during delivery of infusions containing lipids.Teleflex medical has determined that the material used in the manufacture of these stopcocks is not lipid resistant and could be weakened during the administration of lipid solutions. these stopcocks, and the kits containing them, should be used only to administer non-lipid containing solutions. teleflex originally issued a field safety notice (fsn) in march 2009 that highlighted these risks. however, the sample product label in this fsn carried an extra warning not to use 70% isopropyl alcohol on the stopcocks. after further testing, teleflex has determined that these stopcocks (distributed in the united kingdom) can in fact be wiped with 70% isopropyl alcohol solutions without harmful effects. as a consequence, teleflex has now issued an amended fsn in july 2009 with a revised product label.This medical device alert has been issued due to the widespread use of these stopcocks and to ensure that all users are aware of this amended field safety corrective 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
Risk of cessation of therapy due to deterioration of power cord.Fisher & paykel healthcare has received reports of deterioration in the connectors of power cords supplied with their cpap flow generators.A power cord that deteriorates will stop working because of a disconnection in the internal wiring, which may lead to arcing and ultimately could cause a melt or breach of the outer cord sheath (insulation); this may arise near the connector that plugs into the cpap unit.
Acción
Ensure that all users, including patients at home, are aware of the manufacturer’s Field Safety Notice.
Identify affected devices. The model number and lot number are located on the bottom of the CPAP device. Remove the water chamber or empty it before viewing the bottom of the device.
Contact the manufacturer to arrange for a replacement power cord. In the interim users should continue with their CPAP therapy.
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
All mackworth healthcare ltd slings fitted with a dosec® clip.
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 issued a field safety notice (fsn) for this device on 15 july 2011, but has not had sufficient confirmation from users that they have received and acted on this information. a copy of the fsn is in the appendix of this alert and it is also available on the mhra website. this alert has been issued in support of the manufacturer’s actions.
Acción
Ensure that relevant members of staff are aware of the problem.
Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.Action by:All those using, managing and maintaining hospital beds. In particular: nurses, maintenance staff and contractors.
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
Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity.
guidant has informed mhra that all serial numbers of contak renewal® 4, contak renewal® 4 avt and renewal® rf devices are subject to a component failure that could result in limited available therapy, inappropriate therapy and a reduction in device longevity. as a precautionary measure, guidant has advised clinicians not to implant affected devices until further notice.
guidant has confirmed that the magnetic switch in these devices has the potential to stick in the closed position, resulting in the inhibition of the device's ability to treat ventricular or atrial tachyarrhythmias. bradycardia pacing remains unaffected. an audible tone, emitted from the device warns patients and/or clinicians of this condition. this component failure will increase the device's battery consumption and significantly reduce device longevity.
to date, guidant has distributed approximately 46,000 of these devices worldwide. there have been five reports, four confirmed and one unconfirmed, of component failure. the four incidents resulted in device replacement. in the uk, 670 devices have been distributed. there have been no reports of this component failure in the uk.
the default setting for these devices is 'enable magnet use on'. for devices already implanted, guidant recommends reprogramming the device to 'enable magnet use off'.
in 'enable magnet use off' mode:
bradycardia pacing and treatment of tachyarrhythmias will continue as programmed if the magnetic switch becomes stuck in the closed position
a magnet will no longer inhibit therapy
temporary suspension of tachyarrhythmia therapy can be performed with a programmer
the time between elective replacement indicators (eri) and end-of-life (eol) may be shortened.
Acción
See actions on page 2.
Do not implant these devices until further notice from Guidant.
Immediately segregate all unimplanted devices and return them to Guidant in accordance with their instructions.
Review patients already implanted with these devices and verify device function using normal follow-up procedures.
Instruct patients to go to a hospital Accident and Emergency department immediately or to contact their clinician if they hear bleep tones from their device.
Consider programming device to 'Enable Magnet Use OFF'.
Ensure that follow-up intervals are no greater than three months (as per instructions for use).
Consider prophylactic explantation if the proposed programming option does not meet patient needs.
Report all instances of device failure to MHRA and Guidant.
Report explants to the National Pacing and ICD Database (see contacts).
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
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
Recall of smartseal™ pressuriser as the outer pouch seal may be compromised.
depuy cmw is recalling smartseal™ pressurisers used during cemented total hip joint replacement surgery, because the outer peelable pouch seals may be creased and therefore may not be intact. the inner peelable pouch seals are intact and therefore the device is likely to remain sterile.
depuy cmw is recalling this product as a precautionary measure. the manufacturer is currently investigating the root cause of the packaging problem.
the mhra is not aware of any incidents associated with these affected devices.
the manufacturer estimates that about 15,000 potentially affected devices have been distributed in the uk since april 2005. the manufacturer wrote to users about this recall in july 2007 (see mhra website). however, only 5% of the affected devices had been returned to the manufacturer by 04 october 2007.
this notice is intended to facilitate the manufacturer’s recall.
Acción
Identify and quarantine affected devices.
Do not use affected devices.
Return affected devices 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
Causa
Poor contact between timesco stubby handles and timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation.
timesco believe that there may be a possibility that the electrical contact on the stubby handle may become bent out of position when used with an early design of callisto disposable blade (pre november 2003), which depressed the bulb slightly more than the current timesco callisto single-use design and other timesco reuseable blades. this could have resulted in the bulb failing to be lit if the handle was subsequently used with any current timesco design blade. the stubby handle electrical contact is shown in figure 1 below.
timesco sent a letter to inform customers of this issue in february 2007 and, as a precautionary measure, they implemented a redesigned contact mechanism in the stubby handle in january 2007
figure 1. stubby handle electrical contact.
Acción
Identify all stubby handles that are currently in use.
Regularly check that the contact spring is adequately elevated to make good contact with the laryngoscope bulb when the bulb is depressed.
Check the function of the handles before each use.
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
Unexplained groin pain.
the need for early revision due to periprosthetic soft tissue necrosis.
the ultima tps femoral stem and ultima metal-on-metal articulation (femoral head plus metal acetabular cup) is a total hip replacement system that has been on the market in the uk since 1997. the ultima tps femoral stem is still available but the ultima metal-on-metal femoral head and acetabular cup were discontinued in 2005.
up to april 2007, one uk study has reported 43 revisions (from a cohort of 637 hips) associated with extensive periprosthetic soft tissue necrosis. some also involved late dislocation or periprosthetic fracture. the revisions were required one to seven years after implantation. there have been no other confirmed reports.
when these stems were explanted, extensive corrosion was observed on the surface of many of them within the area of the cement mantle. this level of corrosion of cemented polished cobalt chromium molybdenum stems has not previously been reported in the orthopaedic literature and the explanation for it is unclear.
depuy has already communicated this information to uk hospitals that implanted these devices. a copy of their letter, including recommendations for imaging and patient management, is in the appendix.
Acción
Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision.
Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer 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
Causa
Extension of recall of implants which may have incorrect alloy composition.
as a result of a manufacturing error, some knee implant components have been made from an alloy of incorrect composition.
in november 2007, the manufacturer recalled some affected products and provided the mhra with a list of uk affected products (see appendix (in pdf only) - rows in grey). the mhra issued
mda/2007/092
relating to this recall, on 4 december 2007.
the manufacturer extended the recall in december 2007 (see appendix (in pdf only) for full list of uk affected products).
520 affected products have been distributed to uk hospitals since june 2007.
the clinical implications for patients implanted with affected products are currently being assessed. the manufacturer’s initial risk assessment is that there is no indication of any health risk to patients as a result of the higher iron content in these devices. the manufacturer is, however, carrying out further tests in order to
fully assess the situation. the mhra will issue further advice on patient management when this assessment has been completed.
Acción
Do not implant affected products (lot numbers listed in Appendix).
Quarantine all affected products and return them to the manufacturer.
Report revisions or adverse incidents related to affected products to 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
Causa
Implants may have incorrect alloy composition.
as a result of a manufacturing error, some products have been made from an alloy of incorrect composition. 142 affected products have been distributed to uk hospitals since june 2007.
the clinical implications for patients implanted with affected products are currently being assessed.
the mhra and/or the manufacturer will issue further advice on patient management when this assessment has been completed.
the manufacturer has provided the mhra with a list of affected products in the uk (see appendix).
Acción
Do not implant affected products (lot numbers listed in appendix)
Quarantine all affected products and return them to the manufacturer
Report revisions or adverse incidents related to affected products to 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
Causa
Extended charge times and inability to deliver therapy at battery voltages close to elective replacement indicator (eri) for a subset of the above devices.
since 1999 medtronic has issued a series of advisory notices concerning the performance of some gem® dr and micro jewel® ii icds.
medtronic's most recent advisory notice is appended to this alert and updates previous follow-up recommendations for affected gem® dr and micro jewel® ii icds. this most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified eri at 4.91v, or during the following period to end of life (eol), specified at 4.57v. the mhra is publishing this medical device alert to reiterate the recommendations made by medtronic, and to update and replace advice previously issued by the medical devices agency in ptn no. 80.
Acción
Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999.
Identify patients affected by referring to the serial numbers listed in Appendix 2.
Follow the detailed instructions given in Medtronic's Advisory Notice (see Appendix 1).
Carry out the following actions for all affected patients (refer to list of serial numbers):
battery voltage of
5.16V or less
,
charge time of
18 seconds or greater
.
Trust managers should ensure that measures to implement the actions specified above are planned and completed within the following SABS deadlines:
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
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
Risk of anaesthetic overdose.
the mhra is aware of an adverse incident that occurred at the beginning of 2005 during the use of an anaconda. it is believed that the adverse event was caused by a combination of user error and inconsistencies in the instructions for use. sedana medical have taken over as the manufacturer of the anaconda and corrected these inconsistencies. the current version of the instructions for use is ifu 7 691 300-r001, published in july 2005 (available at
www.Sedanamedical.Com
(external link)).
sedana medical is implementing changes to the design of the system to eliminate the luer connection between the syringe and the anaconda and is making additional changes to the instructions for use. sedana medical estimates that these changes will be introduced on new products at the end of 2006.
Acción
Check that there are procedures in place to ensure that the AnaConDa device is only used:
according to the current version number of the instructions for use (At the time of publishing this is version number 9 691 300-R001, issued in July 2005)
by clinicians specifically trained in the use of anaesthetic drugs
with the correct level of monitoring and respiratory support, as recommended by the AAGBI (Recommendations for standards of monitoring during anaesthesia and recovery, 3rd edition, 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
Causa
Failure to defibrillate. the manufacturer is recalling a specific batch of these defibrillators to correct a malfunction that prevents or delays the delivery of therapy, which can lead to failure to resuscitate a patient. this recall is in addition to a batch of aed 20 defibrillators recalled in july 2006 to correct a similar malfunction (mda/2006/047).
a malfunction is caused by an intermittent connection between a pin and socket on a circuit board inside the defibrillator. the problem develops over time and is unpredictable. the aed 20 has a self-monitoring feature that detects this problem and displays a ‘defib comm’ error message. the problem is often identified while the device is being tested before use but has also occurred while practitioners are attempting to use the device on a patient.
the manufacturer issued recall letters to their distributors on 29 august 2007.
this is an extension of a recall covered by
mda/2006/047
issued in august 2006.
the manufacturer is offering loan devices whilst those affected are being upgraded free of charge.
Acción
Identify affected devices using the list of serial numbers in the appendix.
Contact the manufacturer to arrange service and upgrade as soon as possible.
Consider if it is appropriate to substitute alternative defibrillators for those affected devices that are in service but are awaiting upgrade.
If affected devices awaiting upgrade are used and display a ‘Defib Comm’ error message, the manufacturer has advised that switching the device off and then on again may clear the error message.
The equipment maintenance records should be updated when upgraded units are returned.
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
Detachment of control threads.
mhra has received 19 reports of detachment of control threads from flexi-t 300 intrauterine devices. most of the reported incidents relate to batch number 01a1. batch details are not available for the remaining incidents. batch 01a1 was manufactured in 2001 and the last uk delivery date for this batch was 01 may 2003.
the control threads may become detached on attempting to remove the device, making removal more difficult.
the manufacturer issued advice to customers in 2003 and issued a reminder in january 2005 (see appendices 1 and 2).
mhra is issuing this alert to ensure that all healthcare professionals involved in the placement and removal of these devices are aware of the manufacturer's advice on how to proceed in cases of difficult removal and on the use of anaesthesia. please note that the local anaesthetic described in the expert report from the manufacturer (appendix 2) is not licensed for this indication in the uk. if a local anaesthetic is necessary, please use an appropriate alternative.
Acción
When removing these devices ensure that:
you have read the attached information from the manufacturer
you have access to small clamps for device removal in case of thread detachment.
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
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
Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect.
patients with revision knee replacements may have received a tibial insert with a manufacturing defect. the affected devices have an incorrectly machined stabiliser post recess, which prevents the tibial insert from fitting correctly over the stabiliser post. the manufacturer has contacted all uk users to recall the affected devices (see the manufacturer’s field safety notice in appendix). 112 affected devices were distributed in the uk. as a result of the recall, 73 unused devices have been returned to the manufacturer. the remaining 39 devices may have been implanted in patients.
patients who have received these implants are at risk of loosening, excessive wear and/or fracture of components. these could be caused by any of the following reasons:
the gap between components was not detected during assembly
excessive force was required to seat the insert with the base plate
a smaller stabiliser post from a smaller sized insert was used to complete the surgery.
Acción
Do not implant affected devices
Identify any affected stock that has not been implanted, and return to manufacturer
Follow the patient management recommendations in this alert.
Do not implant affected devices
Identify any affected stock that has not been implanted, and return it to the manufacturer
Identify which patients have been implanted with affected devices
Ensure that affected patients, including those without symptoms, are followed up in accordance with usual standards of care for revision knee replacement patients (the manufacturer recommends follow-up at 6 weeks, 6 months, 12 months, and annually thereafter)
Advise patients implanted with affected devices to report any increasing pain, or any symptoms of knee instability such as clicking
Consider the need for revision for symptomatic patients.
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
Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off.
following the investigation of a returned bedside model 4170 temporary cardiac pacemaker, the manufacturer has concluded that there is a potential for rapid pacing to occur when shutting off the device. this can only occur if there is a failure of a specific electronic component within the pacemaker box, and the rapid pace switch is left on.
apc medical ltd issued an advisory notice on 09 november 2007 to all affected uk centres.
the manufacturer has developed a software modification to eliminate the possibility of rapid pace pulses from occurring on shutdown. they have requested that all affected pacemakers are returned to them for appropriate upgrade. the temporary cardiac pacemaker can be used while awaiting upgrade provided the rapid pace switch is off when shutting down the device.
Acción
Check that the rapid pace switch is turned off before shutting down the device.
Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade.
Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.