NI
Report
- Report Number
- 1416980-2023-04178
- Event Type
- Malfunction
- Date Received
- August 18, 2023
- Date of Event
- July 25, 2023
- Report Date
- August 18, 2023
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, LIQUID WAS FOUND DURING USE OF THE HOMECHOICE CASSETTE, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT A HOMECHOICE CLARIA DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED NEAR THE END OF PERITONEAL DIALYSIS (PD) THERAPY. WHEN THE HOMECHOICE CASSETTE WAS REMOVED, A SMALL QUANTITY OF LIQUID WAS FOUND AROUND THE LEFT AND RIGHT DISPOSABLE MEMBRANE GASKET HYDRAULIC VALVE OF THE CLARIA DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2166975 | NI | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE CORPORATION | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | HOMECHOICE CLARIA| UNSPECIFIED PD SOLUTION |