| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00855-1 |
| Product Name/Description |
HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD System
HomeChoice PRO Automated PD Cycler, 230V
Product Code: R5C8320
HomeChoice Claria APD System, 115V/230V
Product Code: 5C6M10
All Serial Numbers
ARTG Number: 172780 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare has been made aware that users may not be following the instructions in the Operator’s Manual and incorrectly opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers.
The HomeChoice cycler operator’s manual specifically warns the operator to open the disposable set packaging by hand and not use tools that may damage the cassette sheeting. Do not use knives, scissors, clamp accessories, or other objects to open the disposable set packaging. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region, and the cycler may deliver air into the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is requesting customers:
1. As stated in the At-Home Guide, open the packaging of the disposable set by hand. Do not use any sharp object to open the packaging;
2. Be aware that flow of fluid out of the connector at the end of the patient line after the prime phase of PD therapy is a visual indication of the potential for air delivery due to an undetected hole over the patient valve area in the cassette sheeting. Baxter will be updating the labelling to include this observation.
3. Complete the Customer Reply Form and return it as per the instructions in the customer letter; and
4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
This action has been closed out on the 16/11/2018. |
| Contact Information |
02 8845 1601 - Baxter Healthcare |