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Sleep-Safe tubing systems – used in peritoneal dialysis

Recall – risk of infection due to leakage

22 December 2016

Consumers and health professionals are advised that Fresenius Medical Care Australia, in consultation with the TGA, is recalling Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Set Paed patient and drainage lines manufactured before September 2016.

Sleep-Safe tubing systems are used during peritoneal dialysis, a process which removes toxins and waste products from the bodies of people with kidney disease. These products can be used in hospitals and by patients for self-treatment in their homes.

It has been identified that patients using these products may experience leakage caused by overwelded coils, which can lead to difficulties in unrolling the tubing that can create pinholes in the lines. This damage may not be visible and will not be detected by the system’s Sleep-Safe cycler.

If this occurs, there is a risk of the patient developing an infection, such as peritonitis (inflammation of the membranes of the abdominal wall and organs).

The welding process for these products was improved in September 2016, meaning lines manufactured after this time are not affected by this issue.

The affected batch numbers are:

  • Sleep-Safe Set
    • XAS131
    • XCS241
  • Sleep-Safe Set Plus
    • XBS011
    • XBS252
    • XBS253
    • XCS221
    • XES09100
    • XES10100
    • XES12100
    • XES17100
    • XES31100
  • Sleep-Safe Set Paed
    • XAS221
    • XBS043

Information for consumers

If you or someone you provide care for uses Sleep-Safe tubing sets, you should be contacted by the peritoneal dialysis unit at your hospital or your Fresenius Medical Care Australia representative to arrange replacement of affected products.

You will also be provided further information about this issue, including correct handling instructions for Sleep-Safe tubing sets.

While you are awaiting replacement lines, you can continue to use the products you have in accordance with the correct handling instructions.

In particular, remember to:

  • unroll Sleep-Safe tubing sets carefully
  • discard the sets if unrolling is not possible
  • if unrolling is successful, carefully check the patient line for leakages during priming.

If you think you have affected products but have not been contacted, or if you have any questions or concerns about this issue, contact the peritoneal dialysis unit at your hospital or your Fresenius Medical Care Australia representative.

Information for health professionals

Fresenius Medical Care Australia has contacted hospital peritoneal dialysis units, and in some cases patients directly, to provide further information about this issue including details of the recall process.

If you are treating a patient who uses Sleep-Safe tubing sets and they have any questions or concerns about this issue, advise them to contact the peritoneal dialysis unit at their hospital or their Fresenius Medical Care Australia representative.

If you have any questions or concerns, contact Fresenius Medical Care Australia on 1800 011 464 (NSW/ACT), 1800 012 808 (VIC/WA/TAS), 1800 011 848 (SA/NT/QLD).

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.