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03 Apr 2019

CLH Blog - MHRA Field Safety Updates For March 2019

CLH Blog - MHRA Field Safety Updates For March 2019

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.

We would first like to bring attention to something in relation to BREXIT.  The MHRA have issued guidance and publications on a possible no deal scenario and information about the regulation of medicines and medical devices if the UK leaves the EU with no deal can be found here.

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.

 

Allergan Pharmaceuticals Ireland - Ozurdex implant recall - Product Recall 

Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached. In October 2018, Allergan recalled certain batches of OZURDEX® product due to the potential for a silicone particle from the needle sleeve to be implanted into the eye during product administration (EL (18)A/16).

At the time of the initial recall, there were some unexpired batches on the UK market where additional testing had not identified the defect but it could not be ruled out. These batches were not recalled.

Since sufficient replacement stock is now available these batches (listed above) are now being recalled by Allergan as agreed.

A copy of the Dear Healthcare Professional Communication issued by Allergan on 28 February 2019 is attached below.

Product information:

Ozurdex 700 micrograms intravitreal implant in applicator (Dexamethasone)

Batch number Expiry date:

  • E77679 04/02/2019
  • E78070 22/02/2019
  • E78276 07/04/2019
  • E78460 09/05/2019
  • E79045 22/08/2019
  • E81736 23/08/2020
  • E82243 25/10/2020
  • E82876 12/02/2021

FSN Date: March 2019

 

Vyaire - enFlow® IV fluid and blood warmer - Medical Device Alert 

Cartridges with an aluminum warming plate in the fluid pathway can lead to an IV infusion containing aluminum above currently recommended safe levels.

enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminum leaching from the device.

FSN Date: March 2019

 

Philips - Pagewriter Cardiographs - Medical Device Alert 

(TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017).

This problem affects lithium-ion batteries that have exceeded their specified replacement interval or number of charging cycles.

Action:

Identify all affected devices using the manufacturer's Field Safety Notices (FSNs) for the TC Cardiograph and the Efficia monitor.

Contact Philips to confirm receipt of each FSN using their response form.

For TC Cardiographs:
Check if the battery has exceeded 300 charge-discharge cycles or if the battery state of health is less than 80%. If necessary, replace the battery in accordance with the instructions in the FSN. Contact Philips to order replacement batteries.
Ensure that systems are in place to routinely assess battery condition. Philips are developing a software update that will assist in battery management and will contact you once this is available.

For Efficia Monitors:
Install the software update (version A.01.11) described in the FSN
Once installed, the device will indicate via an error message if battery replacement is necessary. Contact Philips to order replacement batteries.
Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

FSN Date: March 2019

 

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

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