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07 Apr 2017

CLH Blog - MHRA Field Safety Updates For March

CLH Blog - MHRA Field Safety Updates For March

As we do every month, we’ve scoured all of the field safety updates for the last month and have put together a roundup of all the most relevant MHRA updates. This is our twelfth field safety updates post and our fourth of 2017 - like always it focuses on updates for health care products and equipment that are relevant to UK care homes and other health 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’s important to immediately act on it.

 

Coloplast, Multi-Organ Procurement Catheter - Recall

The Mutli-Organ Procurement Catheter with catalogue number AJ6516 and lot numbers 4893648 - 4709982 - 5066441 - 5260931 - 5260932 are being recalled from the market urgently.

The catheter is packed in an internal PE pouch which is placed in a sterility pouch (PE/paper). This sterility pouch is placed in a retail box. There is one product per retail box. COLOPLAST has become aware of packaging anomaly on the above mentioned lots. The reason of the recall is that there might be some of the pouches of the above mentioned lots that could be defective and compromising the sterility of the device. The non sterility of device may lead to a risk of infection for the patient.

All expenses will be refunded by Coloplast. Please see address below. Distribution Center of Coloplast Champlan Recall AJ6516 Service Retour 2 bis route du Chemin Blanc ZAC du Clotais 91160 CHAMPLAN France Please contact Supply Chain Customer Service for assistance e-mail: gbcma@coloplast.com or phone: 01733 368739.
 

B Braun Medical, Proset Infusomat Space Line Pur / 0.2 - Corrective Action

It has been noted that the pump section on some lines has been mounted in reverse direction, which could potentially lead to incorrect fluid delivery. The affected products are limited to article number 8251284SP and batch 17A03F00B1.

If you have one of the affected sets, it is recommended that it is quarantined immediately and should not be used. To send the affected products back, contact B Braun Medical - you will receive a replacement.
 

BD, BD Vacutainer® SST™ II Advance Plus Blood Collection Tubes - Product Recall

BD Life Sciences – Preanalytical Systems is issuing a recall for catalogue code 366882, BD Vacutainer® SST™ II Advance Plus Blood Collection Tubes, lot number 6309990.

Through internal checks, BD has become aware that the labelling for the tube, shelf and case packs for this lot number have been incorrectly printed with a shelf life of 18 months, as opposed to the correct 12 month shelf life.

It is recommended that use of the affected lot is discontinued, with products being destroyed or returned to BD.
 

Physio Control, Lifepak 1000 Defibrillator - Corrective Information

Physio-Control has received 34 reports of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly during patient treatment. This unexpected shutdown is due to an intermittent connection between the battery and device contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death.

There have been eight adverse events related to this issue. It has been determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This has been observed to occur in devices that are exposed to vibration and have a battery installed for extended time without being removed from the LIFEPAK 1000 for inspection and then reinstalled. The LIFEPAK 1000 Defibrillator Operating Instructions instruct users to inspect the battery well and battery contacts routinely as part of the maintenance and testing schedule.

The steps to take:

For the Device:

1. Immediately remove and reinstall the battery from your LIFEPAK 1000 defibrillator. The removal and reinstallation of the battery will clean the contacts of oxidation and will restore power to the device.
2. It is critically important that you implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. Removing and reinstalling the battery on a weekly basis will help ensure your device is ready for use. It is also important to always carry a spare, fully charged battery. This weekly schedule of battery removal must be performed until your device correction has been completed.

For the Notification:

1. Please forward this information to all of your sites, trainers and users who have LIFEPAK 1000 device(s).
2. Follow the instructions on the Confirmation Sheet for each device in your possession as indicated by serial number listed. Promptly return the completed Confirmation Sheet to Physio-Control.

MDA/2017/013

Field Safety Notice
 

Medtronic, Curity Eye Pad Oval and Curity Eye Pad Sodium Chloride Dressing - Product Recall

It has been identified that there is potential for the sterile packaging of these two dressings to be compromised, which is why these products are being recalled. Using the affected products may result in a higher risk of infection for patients. As it stands, there have been no reports of infection associated with use of this product.

The affected products should be quarantined and returned to Medtronic, who will issue replacement products. The affected products are the Covidien Curity Eye Pad Oval, item code 2841, lot number beginning with 12, 13, 14 15, 16, with expiration dates from 2017-02 through to 2021-11. The Covidien Curity Sodium Chloride Dressing is all affected, with item code 3339, lot numbers beginning with 14, 15, 16, and expiration dates from 2017-02 through to 2019-11.

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