FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 2870328
·
Received December 12, 2012
Report
- Report Number
- 1416980-2012-07138
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST DUE TO THE FAILED VOLUME ACCURACY TESTING. THE ASSIGNABLE CAUSE FOR THE FAILED VOLUME ACCURACY TESTING WAS DETERMINED TO BE DETERIORATED PISTON FOAM. THE DEVICE WAS SENT TO SERVICING.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. IN FILL 1 THE MEASUREMENT WAS 827.4ML, DRAIN 1 THE MEASUREMENT 827.7ML, FILL 2 THE MEASUREMENT WAS 829.3ML, AND DRAIN 2 THE MEASUREMENT WAS 829.3ML. THE ALLOWABLE RANGE IS 774ML - 821ML. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE PRO | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |