Device product
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Z-3041-2017
Product summary
- Event
- Event 77711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23732 units
- Official record key
device-enforcement:Z-3041-2017
Official wording
Reason: Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. 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.
Code information: all codes
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. 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.