The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning HomeChoice PRO Automated Peritoneal Dialysis (PD) System with product code R5C8320, manufactured by Baxter Healthcare.
The manufacturer is implementing additional warning in HomeChoice/HomeChoice PRO device product labelling related to patients more vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill.
Specific populations using PD therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. Overfilling with dialysate (IIPV) or not draining enough fluid during PD therapy can result in excess fluid in the abdomen accompanied by patient symptoms.
The manufacturer 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.
The manufacturer also advises customers that if unintended increased intraperitoneal volume (overfill) is suspected, they should immediately initiate a manual drain and contact their treating health professional.
For details, please refer to TGA websites:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00304-1 and
http://www.tga.gov.au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 March 2014