HomeChoice Pro automated peritoneal dialysis systems

Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, is recalling a small number of units of its HomeChoice Pro automated peritoneal dialysis system. Affected patients will be provided a replacement unit free of charge.

Automated peritoneal dialysis systems are used to remove toxins and waste products from the bodies of people with kidney disease. The process involves pumping a fluid into and out of the abdomen. Toxins and waste products dissolve into the fluid and are removed from the body.

It has been identified that a potentially faulty part used in a small number of units can cause those devices to cease functioning. If this problem occurs, patients can switch to manual peritoneal dialysis to continue therapy.

Serial numbers of affected units and states where supplied:

• 300905 (Qld)
• 300882 (Qld)
• 300928 (NSW)
• 300889 (NSW)

There had been no reports of adverse events related to this issue in Australia as at 4 November 2013.

Information for consumers

Baxter Healthcare has contacted the suppliers (primarily hospitals) of HomeChoice Pro automated peritoneal dialysis units to provide further information about the above issue and instructions to contact affected patients.

If you are a patient in Queensland or NSW and have a HomeChoice Pro automated peritoneal dialysis unit with one of the above serial numbers and you have not been contacted by the supplier with further information, including details on how to get a replacement unit, or if you have any questions or concerns regarding this issue, contact Baxter Healthcare on 1800 812 740.

Patients should always keep a supply of materials at hand to perform manual peritoneal dialysis. If an automated peritoneal dialysis unit stops working, manual peritoneal dialysis should be undertaken and the treating health professional informed.

Information for health professionals

Baxter Healthcare has contacted the suppliers (primarily hospitals) of HomeChoice Pro automated peritoneal dialysis units to provide further information about the above issue and instructions to contact affected patients.

If you are treating a patient who uses a HomeChoice Pro automated peritoneal dialysis unit and they have not been contacted, or have any questions or concerns about this issue, advise them to contact Baxter Healthcare on 1800 812 740.

Reassure the patient that the above problem does not pose additional risk. The unit will stop working and fluid flow will automatically stop. Advise them to undertake manual peritoneal dialysis if this occurs.

It is advised for all patients undergoing automated peritoneal dialysis at home to be trained in manual peritoneal dialysis and to have adequate supplies to do this if required.

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.