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02 May 2018

CLH Blog - MHRA Field Safety Updates For April

CLH Blog - MHRA Field Safety Updates For April

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.

Cook, Rhapsody H-30® Holmium Laser - Urgent Field Safety Notice

Cook Medical is initiating a voluntary field correction for HL-30C serial numbers LHT-0155-0213 and LHT-0383-0513. For these specific products, Cook Medical has identified that the serial number contained on the placard does not match the serial number contained within the software. This labelling discrepancy does not impact the functionality of the product. Therefore, use of the product does not pose a risk of harm to the patient or end user.

Details on affected devices: Product Brand Name Reference Part Number Global Part Number Serial Number Lot Number Rhapsody H-30® Holmium Laser System HL-30C G23664 LHT-0155-0213 LHT-0383-0513 NS4995207 UF2359075

FSN date: 3rd April 2018

Synthes GmbH, Sciatic Nerve Retractors – 1144719 – Urgent Product Recall

Synthes GmbH is initiating a product removal of the below part and lot numbers of Sciatic Nerve Retractors. These devices are part of the 3.5mm Low Profile Pelvic System and intended for drawing back soft tissue during orthopaedic surgery.

Part Number Part Description Lot Numbers 03.100.013 Retractor f/Sciatic Nerve T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813 03.100.014 Retractor f/Sciatic Nerve long T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061

Reason for Recall: There is the potential for micropores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle. Discoloration and moisture were identified within the packaging of the above-mentioned Sciatic Nerve Retractors indicating that these pores may be present in the affected devices.

FSN date: 4th April 2018

Zimmer Biomet, ZNN & M/DN Guide Wires - Urgent Medical Device Recall

Zimmer Biomet is conducting a lot specific medical device field action (removal) for ZNN and M/DN Trauma Guide Wires due to process monitoring failures related to the sterile seal on the packaging. A breach in the packaging seal could potentially lead to loss of sterility of the device.

Surgeon/ Hospital Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 – Certificate of Acknowledgement and send to fieldaction.uk@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgment form with your field action records in the event of a compliance audit of your facility’s documentation. 5. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative

FSN date: April 11th 2018

Medtronic, MindFrame CaptureTM LP - Field Safety Notice

In February 2018, Medtronic notified customers with unexpired MindFrame CaptureTM LP devices of the potential for devices to partially detach or fully separate from the delivery wire. The initial communication requested customers to remove, quarantine and return affected products to Medtronic. This current letter is an additional communication to provide patient management recommendations in the case you experienced a partial detachment or full separation of the MindFrame CaptureTM LP device where the device or device fragment(s) were retained in the patient’s body.

Issue Description: Partial detachment or full separation of the MindFrame CaptureTM LP device from the delivery wire may lead to vessel damage or a foreign body obstructing the bloodstream. Potential complications or irreversible injuries associated with this issue include but are not limited to: prolonged procedure, incomplete treatment, intimal damage, vasospasm, dissection, intracranial haemorrhage, hematoma, transient ischemic attack, ischemic stroke/cerebral infarction, neurological deficit, and/or death. Of the 22 events reported to Medtronic that are associated with partial detachment or full separation of the MindFrame CaptureTM LP device as of March 16, 2018, there have been a total of three (3) reports of serious injury, which include two (2) reports of death that could potentially be associated with this issue.

FSN date: April 2018

Siemens Healthineers, ADVIA® Chemistry Systems - Urgent Field Safety Recall

Affected products: Nitrogen UN 03040257 10309051 408143 418290 2018-06-28 2018-06-28 2017-03-28/2017-06-09 2017-03-28/2017-07-17.

Siemens Healthcare Diagnostics has confirmed that the Urea Nitrogen reagent kit lots listed in the table 1 above for use on ADVIA® 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. If calibration passes, there is a potential for falsely elevated patient and quality control results. Internal testing has also shown that for the lots listed in table 1, results have the potential to be falsely increased by approximately 10 mg/dL across the analytical range. Quality controls may not always detect the elevated results. Siemens is currently investigating the root cause of this issue.

FSN date: April 2018

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