Events

Recall of sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Medical Care Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01612-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01612-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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 .

Device

sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)
  • Model / Serial
    sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed(Tubing sets for Peritoneal Dialysis)sleep.safe SetBatch Numbers: XAS131, XCS241sleep.safe Set PlusBatch Numbers: XBS011, XBS252, XBS253, XCS221, XES09100, XES10100, XES12100, XES17100, XES31100sleep.safe Set PaedBatch Numbers: XAS221, XBS043ARTG number: 123388
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd