CAS Alert: Cease Immediate Use Of Syringe Driver Pumps T34 3 Edition Models

Source: Medicines & Healthcare products Regulatory Agency (MHRA)

Summary

The intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and incompatibility with older versions.

Following the release of the 3rd edition T34 pump, MHRA has received reports of problems associated with using it. This involves, but is not limited to:

  • errors and inconsistencies in the instructions for use
  • incompatibility of the BodyCommTM 88-102 software with 3rd edition pumps
  • changes to battery life
  • use implications due to change in device interface

2nd edition T34 syringe driver pumps (the previous version) are still affected by separate corrective actions addressing the following issues:

  • sunlight protection (MDA/2016/002)
  • battery connection issues (MDA/2019/013)
  • fluid ingress checks (MDA/2019/030)

Actions

  • Identify whether you have any 3rd edition T34 syringe driver pumps (see device details section in the attached CAS alert).
  • Identify patients currently receiving treatment supported by these pumps.
  • Identify all relevant healthcare professionals involved with care delivery using these pumps and advise them to discontinue using the device when clinically appropriate.
  • BD/CME will contact you directly regarding the BodyComm V3.0 software and when the updated version of the IFUs are available.
  • Once you receive the updated IFUs, make sure users are aware of the revised intended use of the pump and other performance specification changes from the previous, 2nd edition, T34 syringe driver pump. BD/CME offers training if required.

Actions by

All technical staff responsible for servicing these devices and healthcare staff who use these pumps.

Deadline for actions

Actions underway: 05 November 2019

Actions complete: 19 November 2019

Click below to view the device details and the full CAS alert:

» Click here to view the full CAS alert

Thank you to Care Uk Knebworth for supplying this image.


CAS Alert: Class 2 Medicines Recall

Summary

M & A Pharmachem is recalling the below batches as a precautionary measure because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination. The fungus has been identified as Penicillium citrinum. It is unlikely that any affected tablets will have got to patient level as the discolouration is noticeable on opening affected packs.

 

Batch NumberExpiry DatePack SizeFirst Distributed
001404/20221 x 100028/09/2017
003207/20221 x 100010/10/2017
003307/20221 x 100019/10/2017
003607/20221 x 100002/11/2017
004007/20221 x 100016/11/2017
004107/20221 x 100022/11/2017
004307/20221 x 100028/09/2017
004508/20221 x 100012/12/2017
004608/20221 x 100003/01/2018
004908/20221 x 100024/01/2018
005008/20221 x 100007/02/2018
005308/20221 x 100015/02/2018
005408/20221 x 100023/02/2018
005708/20221 x 100009/03/2018
006008/20221 x 100028/03/2018
006209/20221 x 100013/04/2018
006509/20221 x 100023/04/2018
006709/20221 x 100030/04/2018
007009/20221 x 100030/04/2018
007109/20221 x 100017/05/2018
007309/20221 x 100024/05/2018
007409/20221 x 100007/06/2018
007509/20221 x 100021/06/2018
007812/20221 x 100005/07/2018
008912/20221 x 100023/07/2018
009801/20231 x 100002/08/2018
010004/20231 x 100013/08/2018
010104/20231 x 100017/08/2018
010204/20231 x 100011/09/2018
010504/20231 x 100002/10/2018
011704/20231 x 100012/10/2018
011906/20231 x 100029/10/2018
012306/20231 x 100012/11/2018
013107/20231 x 100023/11/2018
013307/20231 x 100006/12/2018
014007/20231 x 100014/12/2018
014107/20231 x 100020/12/2018
015810/20231 x 100031/01/2018
015910/20231 x 100011/02/2019
017310/20231 x 100022/02/2019

 

Advice for healthcare professionals

Stop supplying the batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

 

Action Deadline: Within 48 hours of receiving this CAS alert notification

 

Click below to view the device details and the full CAS alert:

» Click here to view the full CAS alert