The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL [Product code 2C1079K; Lot number 15A056 and 15B047], manufactured by Baxter Healthcare.
The manufacturer is issuing a recall for the above affected lots of the INFUSOR PCM, 0.5mL due to complaints for partially detached back-plates on the underside of the device. A partial detachment of the PCM back-plate may cause an incomplete shut-off of the PCM watch tubing resulting in continuous flow of medication from the PCM to the patient.
The manufacturer has identified the root cause of this issue and corrective actions have been implemented. The affected lots were produced prior to implementation of the corrective actions. Continuous flow of pain medication to the patient may result in sedation, respiratory depression, or respiratory failure resulting in the need for medical intervention. These conditions could lead to serious injury or death.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-7-to-11-september-2015
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 September 2015