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 Number | Expiry Date | Pack Size | First Distributed |
| 0014 | 04/2022 | 1 x 1000 | 28/09/2017 |
| 0032 | 07/2022 | 1 x 1000 | 10/10/2017 |
| 0033 | 07/2022 | 1 x 1000 | 19/10/2017 |
| 0036 | 07/2022 | 1 x 1000 | 02/11/2017 |
| 0040 | 07/2022 | 1 x 1000 | 16/11/2017 |
| 0041 | 07/2022 | 1 x 1000 | 22/11/2017 |
| 0043 | 07/2022 | 1 x 1000 | 28/09/2017 |
| 0045 | 08/2022 | 1 x 1000 | 12/12/2017 |
| 0046 | 08/2022 | 1 x 1000 | 03/01/2018 |
| 0049 | 08/2022 | 1 x 1000 | 24/01/2018 |
| 0050 | 08/2022 | 1 x 1000 | 07/02/2018 |
| 0053 | 08/2022 | 1 x 1000 | 15/02/2018 |
| 0054 | 08/2022 | 1 x 1000 | 23/02/2018 |
| 0057 | 08/2022 | 1 x 1000 | 09/03/2018 |
| 0060 | 08/2022 | 1 x 1000 | 28/03/2018 |
| 0062 | 09/2022 | 1 x 1000 | 13/04/2018 |
| 0065 | 09/2022 | 1 x 1000 | 23/04/2018 |
| 0067 | 09/2022 | 1 x 1000 | 30/04/2018 |
| 0070 | 09/2022 | 1 x 1000 | 30/04/2018 |
| 0071 | 09/2022 | 1 x 1000 | 17/05/2018 |
| 0073 | 09/2022 | 1 x 1000 | 24/05/2018 |
| 0074 | 09/2022 | 1 x 1000 | 07/06/2018 |
| 0075 | 09/2022 | 1 x 1000 | 21/06/2018 |
| 0078 | 12/2022 | 1 x 1000 | 05/07/2018 |
| 0089 | 12/2022 | 1 x 1000 | 23/07/2018 |
| 0098 | 01/2023 | 1 x 1000 | 02/08/2018 |
| 0100 | 04/2023 | 1 x 1000 | 13/08/2018 |
| 0101 | 04/2023 | 1 x 1000 | 17/08/2018 |
| 0102 | 04/2023 | 1 x 1000 | 11/09/2018 |
| 0105 | 04/2023 | 1 x 1000 | 02/10/2018 |
| 0117 | 04/2023 | 1 x 1000 | 12/10/2018 |
| 0119 | 06/2023 | 1 x 1000 | 29/10/2018 |
| 0123 | 06/2023 | 1 x 1000 | 12/11/2018 |
| 0131 | 07/2023 | 1 x 1000 | 23/11/2018 |
| 0133 | 07/2023 | 1 x 1000 | 06/12/2018 |
| 0140 | 07/2023 | 1 x 1000 | 14/12/2018 |
| 0141 | 07/2023 | 1 x 1000 | 20/12/2018 |
| 0158 | 10/2023 | 1 x 1000 | 31/01/2018 |
| 0159 | 10/2023 | 1 x 1000 | 11/02/2019 |
| 0173 | 10/2023 | 1 x 1000 | 22/02/2019 |
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: