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02 Nov 2018

CLH Blog - MHRA Field Safety Updates For October 2018

CLH Blog - MHRA Field Safety Updates For October 2018

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Medtronic - Puritan Bennett™ 980 (PB980) ventilator series - Urgent Field Safety Notice

Medtronic is releasing maintenance software update MR5.4 for all models of Puritan Bennett™ 980 (PB980) ventilator series. Reason for voluntary correction This software update for PB980 ventilators is being deployed to address routine customer feedback and complaints and concerns raised by Australia’s regulatory authority, the Therapeutic Goods Administration (TGA). This maintenance software update also provides additional product enhancements.

The concerns raised by TGA surround External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation. Risk to health While there have been previous reports of patient transfer in the event of ventilator GUI malfunctions in general, in this case, there have been no such reports. To date, there have been no reports of serious injury or death associated with any of the changes associated with this software release. Based on Medtronic’s internal data analysis and a thorough review of potential patient safety risk, we conclude that there is remote risk to patients. As such, we are advising that you can continue to use your PB980 in accordance with your institutional policies.

FSN date: October 2018

Medtronic - Medtronic MiniMed™ 640G (MMT-1711, MMT-1712) Potential Loss of Audio Issue - Urgent Field Safety Notice

Medtronic received reports of occurrences in which the MiniMed™ 640G insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This failure could either cause the alarm volume to be fixed at a 4 (out of 5) level regardless of your patient’s personal setting or it could switch the volume to OFF. Either of these occurrences could cause your patient to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low blood glucose alerts. The purpose of this letter is to make you aware that we will be notifying all patients who may have one of the potentially affected insulin pumps.

Explanation of Issue: This issue occurs when a specific electronic component in the pump malfunctions. It can result in the loss of all audio, problems adjusting the audio volume, or the loss of only the emergency audio siren. This potential loss of audio could delay the patient’s ability to respond to the underlying reason for the alert, alarm, or siren, which could then lead to possible health and safety risks such as hypoglycemia or hyperglycemia. If this issue occurs with the pump, the audio cannot be permanently repaired or regained. The only way to permanently regain the audio capabilities is to exchange the affected pump with a replacement. Even if the pump has the audio issue, it will continue to deliver insulin as expected. Loss of the ‘’vibrate’’ feature has not been reported to occur as part of the above audio failure mode. If the pump contains the specific electronic component, and the pump passes the Audio Beep test described below, there is still a chance that the pump may malfunction and lose its audio capabilities at a future date.

FSN date: October 2018

Smith & Nephew - GII MIS DCF DISTAL CUT BLOCK - Field Safety Product Recall

Smith & Nephew Inc., have voluntarily initiated a recall to remove multiple lots of GII MIS DCF CUTTING BLOCKS due to a manufacturing error. The tab thickness on the GII Distal cutting block was manufactured too small and will not allow the instrument to lock with the GII Distal Alignment guide. This field action has been reported to the relevant competent authorities.

Risks to Health In the event the affected device is presented for use, the cutting block will not lock and a backup device will be used to complete the procedure. However, in the worst case if a backup device is not available the cutting block would be used without the locking mechanism, potentially causing procedural problems.

Actions to be taken by the user 1. Locate and quarantine affected unused devices immediately. 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Notice for Recall is terminated to ensure the effectiveness of the action.

FSN date: 4th October 2018

Biomerieux - NUCLISENS® Lysis Buffer ref. 280134 lot Z019EA1LB exp. 28-MAY-2019 - Urgent Product Safety Correction Notice

Description of the issue Following a customer complaint about colored eluates, bioMérieux investigation has confirmed an issue with this specific lot Z019EA1LB of NUCLISENS® Lysis Buffer ref. 280134. The investigation confirmed that some eluates become colored because of remaining hemoglobin in the eluate; however only samples naturally containing (or potentially contaminated with) hemoglobin could generate this issue (i.e. Whole Blood samples, Dry Blood Spots and Stools). The root cause of the coloration is linked to the pH that, for lot Z019EA1LB, has been observed to be 6.96 at 21,0°C instead of [7,0 – 7,2] as per product specification and also linked to possibly poor sample quality (non homogeneous or partially lysed samples).

The issue is randomly observed and with a low occurrence. Impact to customer: The presence of hemoglobin could cause the inhibition of the PCR resulting, in most of the cases in uninterpretable test results as also the extraction internal control (IC) would be inhibited, invalidating the test. In this case, there is a potential risk related to possible delayed results. Considering that the NUCLISENS® Lysis Buffer is used in various protocols and downstream applications and assuming a conservative approach and the worst case scenario in which the IC would not be inhibited, or not used although it is part of good laboratory practices, the tests run with colored eluates could potentially result in false negative results.

FSN date: 10th October 2018

We’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroup to let us know and don’t forget to use '#CommittedToCare' in your posts.

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