| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00304-1 |
| Product Name/Description |
HomeChoice PRO Automated Peritoneal Dialysis (PD) System
Product code: R5C8320
All systems affected
ARTG number: 172780 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare 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 Peritoneal Dialysis (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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The additional warning identifies symptoms related to unintended IIPV that may occur in specific patient populations and provides specific instructions to the patient and/ or caregiver to follow if IIPV is suspected.
For more details, please see http://www.tga.gov.au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.htm . |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |