HomeChoice PRO automated peritoneal dialysis system

Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, is undertaking a recall for product correction of its HomeChoice Pro automated peritoneal dialysis system.

The recall for product correction will add additional precautionary warnings to the Instructions for Use of the HomeChoice PRO dialysis system. The additional product warnings relate to patients who are more vulnerable to unintended increased intraperitoneal volume, also known as overfill, and advises patients and carers on actions to take if this occurs. These vulnerable patients include newborn babies, infants, small children and any patient with significant heart or lung disease.

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.

The additional product warnings relate to patients who are more vulnerable to unintended increased intraperitoneal volume, also known as overfill, and advises patients and carers on actions to take if this occurs.

The decision to add additional warnings follows overseas reports of unintended increased intraperitoneal volume in patients using HomeChoice Pro automated peritoneal dialysis systems. The TGA had not received any reports relating to this issue in Australia as at 14 March 2014.

Information for consumers

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

Symptoms that should alert the patient or carer that excess fluid may have accumulated:

• Neonate/infant: general signs of distress (e.g., fussiness, crying), paleness or bluish skin color, difficulty breathing, refusal to eat, bloated abdomen or persistent vomiting.
• Small child: complaints of feeling full, report of pain in abdomen, persistent crying, difficulty breathing, refusal to eat, bloated abdomen or persistent vomiting.
• Patients with heart or lung disease: difficulty breathing, shoulder and/or chest pain, paleness or bluish skin color.

If unintended increased intraperitoneal volume (overfill) is suspected, immediately initiate a manual drain and contact your treating health professional.

If you are a patient or carer who has a HomeChoice Pro automated peritoneal dialysis unit and you have not been contacted by the health care provider with further information about this issue, or if you have any questions or concerns, contact Baxter Healthcare on 1800 806 923 during office hours.

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.

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 806 923 during office hours.

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.