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.
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 outer sheath and light guide tube of flexible endoscopes may be damaged by prolonged exposure to ultraviolet (uv) light used in these endoscope storage and drying cabinets.
afos (nse) ltd has informed the mhra that some endoscope storage and drying cabinets have been fitted with a non-standard programme that allows the uv light to be switched on for eight hours a day instead of the expected 15 minutes every six hours. the mhra has received a report of significant deterioration to a flexible endoscope that was stored in an afos cabinet fitted with an incorrect programme.
this type of damage to the outer sheath of the flexible endoscope insertion tube and light guide tube may:
cause trauma to the patient;
affect the functionality of the scope;
allow ingress of fluids into the endoscope;
inhibit effective decontamination of the endoscope by allowing micro-organisms to be retained in the damaged area of the endoscope;
reduce the number of endoscopes available for use in the unit whilst the affected endoscope is being repaired.
Acción
Check all flexible endoscopes that have been stored in AFOS endoscope storage facilities for damage.
If the endoscope is damaged do not use it until it has been repaired.
Contact AFOS to ensure that the endoscope storage and drying cabinet has the correct programme for UV light exposure.
Do not use the storage and drying cabinet if it has the incorrect programme fitted.
If no other suitable storage and drying cabinet is available carry out a risk assessment for the continued use of these cabinets for storing endoscopes.
Be aware of MHRA advice given in MDA/2007/034.
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
These, and some other, lancing devices are intended for self-use by one patient only, to take blood samples for self-monitoring. the use of softclix and softclix ii lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis b between patients.
single patient lancing devices e.G. roche accu-chek softclix, softclix ii, softclix plus and multiclix are intended for self-use by one patient only, to take blood samples for self-monitoring. they are not intended for use by healthcare or care workers to obtain blood samples from multiple patients because there is a risk of cross infection and the transmission of blood borne viruses.
the mhra is aware that the inappropriate use of the softclix and softclix ii devices by healthcare and care workers to obtain blood samples from multiple patients has been implicated in recent outbreaks of hepatitis b in care homes in england, in which two patients have died.
Acción
When testing multiple patients, healthcare and care workers should not use single patient lancing devices such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples. When obtaining blood samples from more than one patient healthcare and care workers must ensure that the lancing device that they use is intended for this purpose.
When obtaining blood samples from patients, healthcare and care workers must ensure that they use
either
a lancing device that is intended for use by healthcare and care workers to obtain blood samples,
or
a disposable single-use lancing device (Please see MDA/2004/044 - Lancing devices for obtaining blood samples).
Healthcare and care workers should not use lancing devices intended for single patient use such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples from multiple patients
Lancing devices such as the Accu-Chek Softclix Pro have been developed for use by healthcare and care workers to obtain blood samples from multiple patients. Multiple patient lancing devices and disposable single-use lancing devices are also available from other manufacturers.
Since August 2005 disposable single-use lancing devices have been available on prescription.
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
Conmed and valleylab esus share the same type of footswitch connector but are wired differently. if the footswitches intended for one type of esu are used with the other, the esu will deliver 'cut' waveforms when the 'coagulate' footswitch is depressed, or 'coagulate' waveforms when the 'cut' footswitch is depressed.
Acción
Theatre staff should check, before use, that footswitches operate cut and coagulate outputs correctly as advised in the manufacturer's instructions for use.
Maintenance staff should ensure that all footswitches are labeled for use with the appropriate ESU.
Staff should, as part of planned preventative maintenance, check that footswitches operate the correct cut and coagulate outputs.
Report to the MHRA and the manufacturer any instance where the labelling is not sufficient.
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 due to a manufacturing defect.
medtronic is recalling implicated lots of colorado ii locking nuts.
according to the manufacturer’s report, two thread grooves are missing on the locking nuts. final tightening may cause the locking nuts to tilt and loosen, causing damage to the thread of the bone screw such that the nuts and the bone screws have to be replaced during the same surgical procedure.
the manufacturer has identified that the problem was caused by a manufacturing error and estimates that about 644 potentially affected devices have been distributed in the uk. the manufacturer wrote to users about this recall in september 2007 (see mhra website).
the mhra is not aware of any adverse incidents in the uk associated with this problem.
medtronic is recalling this implant as a precautionary measure. this alert is being published to facilitate the manufacturer’s recall.
Acción
Do not use affected devices.
Quarantine affected devices.
Return affected devices to the manufacturer.
Report all adverse incidents associated with this device to the 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
Repeated exposure to cidex® opa high level disinfectant solution, following manual re-processing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy.
johnson & johnson has issued a product notification, contraindicating the use of cidex® opa for re-processing urological instrumentation for use in patients with a history of bladder cancer. a letter and revised instructions for use were issued on 27 april 2004 to all uk customers that have bought cidex® opa.
a recent post-marketing surveillance review carried out by the company identified that, since the product was introduced in 1999, out of approximately 1 million urological procedures world-wide, there have been reports of 24 patients who have experience 'anaphylaxis-like' reactions after repeated cystoscopy (typically after 4-9 treatments). symptoms reported to the manufacturer included nausea, penile swelling, hypotension, vomiting, breathing difficulty, wheezing, rash, hives, eye irritation, dizziness and anaphylactic shock.
in all of the above cases the manufacturer has indicated that the instruments had been manually re-processed. the evidence for manual re-processing being a significant risk factor is, therefore, compelling.
Acción
When re-processing urological instruments for use inpatients who have potential for repeated exposure:
Do not use Cidex® OPA if a validated alternative is available.
If no validated alternative to Cidex® OPA is available:
carry out a risk assessment on the continued use of this disinfectant solution;
ensure that measures are in place to minimise disinfectant solution residues (e.g. use of a validated endoscope washer-disinfector);
plan and implement the replacement of this disinfectant solution with an alternative.
Where no validated alternative to Cidex® OPA is available and there is potential for repeated exposure, carry out a risk assessment and options appraisal, taking into account the following factors:
Risk factors
In considering risks to patients:
the risk of sensitisation is related to patterns of exposure. In this instance, repeated cystoscopy and ineffective removal of residues are important risk factors associated with the use of Cidex® OPA;
bladder cancer is associated with reactions to Cidex® OPA, but this is likely to be due to repeated cystoscopy, rather than a risk factor per se. Bladder cancer is not associated with increased susceptibility to allergic disease;
trauma associated with cystoscopy, particularly in male patients, may augment allergic reactions.
In considering risks to users:
the company has identified that healthcare workers have experienced irritation or possible allergic reactions due to exposure to Cidex® OPA. It is the company's view that, in most of these cases, the healthcare workers were not using the product in a manner consistent with the instructions for use;
symptoms reported in healthcare workers do not appear to be indicative of Type I hypersensitivity.
Risk control measures
In the short term, residues of Cidex® OPA should be minimised, preferably by the use of a validated endoscope washer-disinfector cycle. If manual processing is carried out, ensure that the manufacturers' instructions for use are followed, in particular during rinsing.
It is not appropriate to use a sensitiser in circumstances where repeat exposure is a possibility and where such use is avoidable. It is therefore necessary to identify an alternative to Cidex® OPA, a suspected sensitiser, in circumstances where there is potential for repeated exposure to patients. Any alternative must be validated for use and compatible with the device and, where applicable, the endoscope washer-disinfector, in line with each of the respective manufacturer's instructions for use.
Further advice on decontamination, including the selection of materials and processes, is available in MHRA Device Bulletin
DB 2002(05) 'Decontamination of Endoscopes'
and NHS Estates publication HTM 2030 'Washer-Disinfectors - Design considerations'.
[Note: endoscope washer-disinfectors may also be described as automated endoscope re-processors (AER)]
DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM
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
Some variants of the puma and beatle are too heavy for standard four point webbing tie-down systems for use in a vehicle.
a basic puma or beatle battery powered wheelchair can be transported using a four point webbing tie-down rated for a 140 kg wheelchair. however, some wheelchairs have additional features such as seat risers,
tilt-in-space functions and powered elevating leg rests etc. therefore, some variants of the puma and beatle battery powered wheelchairs weigh in excess of 140kg and are too heavy for the standard four point webbing tie-down system available for use in a vehicle. guidance on how to verify the weight of the unoccupied wheelchair can also be found in the field safety notice (see appendix). if a vehicle is involved in an impact there is a risk that the tie-down will fail, potentially leading to injury of the wheelchair user and others.
the manufacturer has been unable to recommend a tie-down system for wheelchairs weighing over 140 kg and has issued a field safety notice (see appendix) recommending that they are not used as a seat in transport.
Acción
Trace all Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare.
Advise users of these wheelchairs not to use the wheelchair as a seat in transport when secured using standard four point webbing tie-downs until such time as they can verify that it weighs less than 140kg.
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 loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.
following reports of malfunction from clinicians outside the uk, guidant reviewed the design and manufacturing processes for the ventak prizm® 2 dr icd. the company identified the potential for loss of therapy in all units manufactured on or before 16 april 2002, when corrective measures were implemented.
on delivery of defibrillation therapy, the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and a header component. the resulting discharge current may damage the icd electronics and cause any of the following:
loss of:
arrhythmia detection / therapy delivery
bradycardia pacing output
telemetry/ programming/ interrogation
a red warning screen indicating malfunction
a yellow warning screen indicating 'out of range' shocking impedance.
Acción
See action points on page 3.
Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago.
Replace all devices in which high voltage therapy has been compromised.
Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device.
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
Potential misconnection of the backup oxygen cylinder; the oxygen cylinder inlet is situated alongside an oxygen outlet and both are fitted with the same connector. a misconnection to the oxygen outlet would prevent backup oxygen supply in the event of oxygen pipeline failure.
the use of an oxygen backup cylinder is optional on the primus. if the backup cylinder is required the user must attach the cylinder, connect its oxygen nist fitting and connect the gas pressure sensor before use. the primus has the further user option of an oxygen outlet, which is slightly longer and situated alongside the oxygen cylinder inlet fitting at the back of the primus. this oxygen outlet is the same nist fitting as the oxygen inlet beside it and therefore users can connect the oxygen cylinder to the wrong fitting.
the mhra has received a report of this misconnection, which was not detected in the device’s automated pre-use checks or the pre-use checks recommended by the aagbi (association of anaesthetists of great britain and ireland). the oxygen pressure gauge indicated that the backup oxygen cylinder was full so the misconnection was not apparent to the user.
Acción
Ensure the backup oxygen cylinder’s NIST (non-interchangeable screw threaded) fitting is connected to the appropriate oxygen inlet. The correct connection guide can be found above the gas inlet block at the back of the device.
Users are recommended that pre-use checks should include the disconnection of the oxygen pipeline to ensure the continuity of oxygen supply from the backup cylinder.
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
False results may be observed when using this combination of assay and laboratory analyser.
this combination has not been validated by either manufacturer.
the mhra has received a report from a laboratory of an unrepeatable positive hiv test result. the positive result was not confirmed when further routine testing was carried out. the result was generated using a biokit best 2000 laboratory analyser in combination with the biomerieux vironostika hiv uni-form ii ag/ab assay.
the cause of the false result has not been determined. however, biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. biomerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them.
Acción
Do not use this (or any other) combination of assay and laboratory analyser unless you have verified that the combination of assay and laboratory analyser has been properly validated for safety, quality and performance.
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
Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.
guidant has identified the potential for loss of therapy in all contak renewal® (model h135) and contak renewal® 2 (model h155) cardiac resynchronization therapy defibrillators (crt-ds) manufactured on or before 26 august 2004.
on delivery of defibrillation therapy the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and titanium casing. the resulting high current may damage the crt-d electronics causing one or more of the following:
loss of
arrhythmia detection/ therapy delivery
bradycardia pacing output
telemetry/ programming/ interrogation
partial delivery of intended shock energy.
a red warning screen indicating malfunction
a yellow warning screen indicating 'out of range' shocking impedance.
Acción
See actions on page 3.
Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago.
Replace all devices in which high voltage therapy has been compromised.
Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device.
Report of 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 due to component failure.
guidant has informed mhra that a sub-set of the implantable pacemaker/defibrillators listed above may suffer degradation of a high-stability low-voltage capacitor leading to device malfunction or premature battery depletion. prevalence of device malfunction in the future and the mean time to failure have not yet been established.
contaminated material used in the manufacturing process of a low-voltage capacitor for these devices can cause a leakage of current resulting in appropriate device behaviour or premature battery depletion. one or two of these capacitors are used in each device depending on device design.
guidant has identified the actual failure mechanism and corrective action has now been implemented. based on experience of reported incidents, capacitor failure is likely to occur in the early part of the device's life period; however it is not possible to estimate when capacitor failure will occur. analysis is ongoing to improve understanding of the prevalence and the time to failure of these devices.
to date guidant has confirmed 5 reports of device malfunction associated with this issue out of approximately 27,200 implanted devices worldwide. one device malfunction was discovered at the time of implant; in the other four reports the devices required replacement.
to date, approximately 1,500 potentially affected devices have been distributed in the uk and the republic of ireland. guidant believe that the majority of these have already been implanted. approximately 49,800 affected devices have been distributed worldwide.
guidant issued a letter with patient management recommendations to clinicians in the uk on 28/06/06 (see appendix 1 in pdf).
Acción
See actions on Page 3.
Do not implant affected devices. (See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website)
Immediately quarantine all affected devices and return them to Guidant in accordance with their instructions.
Identify patients implanted with affected devices and review them as soon as possible, giving priority to those who are device dependent or who have not been followed up within the last three months.
During follow-up, verify device function using normal programmer follow-up procedures, checking for:
no telemetry/pacing output
ERI or EOL indications
suspected premature battery depletion
For specific model families, possible device malfunction behaviours may include (but are not limited to):
Incomplete or missing PRM daily measurements
Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings
Fault code 11 upon interrogation
Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings
Battery voltage less than 3.10 V within six months of implant
Abnormal P&R wave measurements
Abnormal signals and markers on real-time or stored electrogram, which may result in inappropriate sensing and therapy
*Not distributed within Europe
Consult Guidant if you identify any of the above.
Consider the risks and benefits of elective device replacement in device dependant patients if any of the above is confirmed.
Schedule future patient follow-ups at intervals of no longer than three months for early detection of device failure.
Instruct patient to contact their follow-up centre immediately or go to a hospital Accident and Emergency department if they experience a slow heart rate, syncope/light-headedness, inappropriate therapy or new or increased symptoms of heart failure.
Report all instances of device failure to MHRA and Guidant.
Report explants to the National Pacing and ICD Database (see Contacts on page 4).