Retiro De Equipo (Recall) de sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)

Recall

RC-2016-RN-01612-1

Class I

2016-12-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01612-1

During the continuous monitoring of sleep safe tubing systems on the market, fresenius medical care has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes, and thus leakages may occur. the possible damage might not be visually detected. the sleep safe cycler can also not detect such a leakage. therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis. the problem of overwelded lines has been analysed and solved in subsequent production.

Fresenius will be contacting patients (users) via hospitals and organising the exchange of potentially affected stock with replacements. In the interim, users are to follow the detailed handling instructions provided in the customer letter. Users are reminded to: - Unroll carefully the tube coils of the sleep safe sets. - If unrolling is not possible, discard the sets. - If unrolling is successful, check carefully the patient line for leakages during priming. For more information, please refer to https://www.tga.gov.au/alert/sleep-safe-tubing-systems-used-peritoneal-dialysis .