The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device safety alert concerning sleep safe sets manufactured by Fresenius Medical Care. The affected article numbers are 5016921 sleep safe Set, 5016931 sleep safe Set Plus, 5017391 sleep safe Set Paed, and 5017491 sleep safe Set Plus (Japanese version). Furthermore, the affected batch numbers of 5016931 sleep safe Set Plus are UGS231, UIS031, UIS032, and UKS091.
During the continuous monitoring of the sleep safe tubing systems on the market, the manufacturer has become aware of possible leakages caused from a small hole at the patient connector which might not be detected by visual inspection. The sleep safe cycler cannot detect such a leakage. Therefore, there is a potential risk of infection for the patient, e.g. the development of peritonitis. So far, no case of peritonitis has been observed due to such a leakage.
The manufacturer recommends users to stop using the affected product batches and they will organize the replacement of the affected sleep safe sets.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON341232
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 December 2013