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CLH Blog - MHRA Field Safety Updates For August - 05 Sep 2018
05 Sep 2018

CLH Blog - MHRA Field Safety Updates For August

CLH Blog - MHRA Field Safety Updates For August

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.

Newdeal SAS - Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile - Field Safety Alert

Risk of infection from compromised packaging. The affected devices are used in various bone and joint reconstruction procedures.

1. Identify and quarantine all affected devices. 2. Locate and return affected devices to Smith & Nephew as detailed in the Field Safety Notice. 3 Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer. 4. Report adverse events involving these devices to your local incident reporting system, the manufacturer, and your national incident reporting authority: England, Scotland, Northern Ireland, Wales.

FSN Date: 1st August 2018

AGFA Healthcare - Enterprise Imaging for Radiology - Field Safety Alert

Device: Enterprise Imaging for Radiology 8.0.0, 8.0.0 SP1 & 8.0.0 SP2. Enterprise Imaging for Radiology 8.0.1, 8.0.1 SP1, 8.0.1 SP2, 8.0.1 SP3, 8.0.1 SP4, 8.0.1 SP5 & 8.0.1 SP6. Enterprise Imaging for Radiology 8.1, 8.1 SP1 & 8.1 SP2. Reference: Problem PRB0056200 - The order of studies in the Clinical Side Bar may not be chronologically sorted after triggering a compare function with a new study.

Problem: Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top. This only happens when additional comparison studies are added for the same patient where the primary patient ID differs, but where there is a match in one of the secondary patient IDs.

While the sort order of the thumbnail images in the clinical side bar may not appear as expected, all images are displayed correctly including dates and other visual indicators when displayed in the image area. Caution should always be taken to avoid selecting the wrong study unintentionally.

FSN Date: August 2018

ELKTA - MOSAIQ - Field Safety Notice

Description of Problem: Leaving the Medication Administration Record (MAR) window open when navigating to the Clinician Worksheet (CWS) can leave the order status in an incorrect state.

Details: - Select a patient who has in-house treat medication orders approved and ready to be administered - Open the Medication Administration Record (MAR) - Select a drug for an in-house order and select Treat - Keeping the Treat window open, open the Clinician Worksheet (CWS) to note any details of the treatment - Go back to the open MAR window The order status is left in state of "Approved (in treatment)". The status should be "Complete".

Clinical Impact: It is not possible to edit the order in this state. An error message is presented saying the order is locked by another user. To get around this, the order has to be unlocked. Unlocking the order will remove the details of the treatment, potentially leaving the order to be mistakenly treated again. If the pharmacy were to fulfill the medication order a second time, depending on the medication, serious injury could result if the medication is given twice.

FSN Date: August 2018

Medtronic - Li-ion battery packs used in BIS™ Vista and BIS™ View Monitoring Systems - Field Safety Alert

Medtronic is issuing a voluntary field correction to revise the replacement instructions for the Li-ion battery packs used in BIS™ Vista and BIS™ View Monitoring Systems. These revised instructions will require battery pack replacement after 4 years. We are issuing this revision due to the potential for aged battery packs to experience an internal short that may result in a thermal event.

Medtronic has received two reports of thermal damage representing a .005% (1 in 20,000) rate of occurrence. In these events, smoke was emitted from the battery compartment on the back of the monitor. No patient or user injury or impairment has been reported for this issue. A thermal event can lead to smoke emission and/or in rare occurrences, fire, potentially resulting in bronchospasm or burns.

FSN Date: August 2018

Medtronic - MiniMed™ remote controller (MMT-500 or MMT-503) - Field Safety Notice

There is a potential security risk related to the Medtronic MiniMedTM 508 and Medtronic MiniMedTM Paradigm™ series insulin pumps when using the corresponding MiniMedTM remote controller.

Explanation of the issue: The Medtronic remote controller, which uses a wireless (RF) radio frequency to communicate with the insulin pump, helps in programming a set amount of insulin (or bolus) into the Medtronic pump discreetly while keeping the device concealed. An external security researcher has identified a potential vulnerability related to the MiniMed™ Paradigm™ family of insulin pumps and corresponding remote controller.

The researcher’s report states that an unauthorized individual in close proximity of an insulin pump user could potentially copy the wireless radio frequency (RF) signals from the user’s remote controller (while they are in the process of delivering a remote bolus) and play those back later to deliver an involuntary bolus of insulin to the pump user. This could lead to potential health risks such as hypoglycemia if additional insulin is delivered beyond the user’s insulin requirements.

FSN Date: August 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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