The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning Sleep-Safe sets [Article numbers: 5016921, 5016931, 5017391, 5017491 and F00005377], manufactured by Fresenius Medical Care.
During the continuous monitoring of the sleep safe tubing systems on the market, the manufacturer has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. Overwelded coils could lead to difficulties in unrolling the patient and drainage line and thus leakages may occur. These possible damages might not be visually detected. The sleep safe and sleep safe harmony cycler cannot detect such a leakage. Therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis.
Until a complete replacement of potentially affected batches is possible, affected users are instructed to take the following handling instructions:-
The manufacturer will arrange replacement of the affected sleep safe sets.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-12-december-16-december-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 December 2016