FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 2890288
·
Received December 29, 2012
Report
- Report Number
- 1416980-2012-08399
- Event Type
- Malfunction
- Date Received
- December 29, 2012
- Date of Event
- October 22, 2012
- Report Date
- December 7, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS CONDITION IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF ANOTHER CONDITION. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DURING REVIEW OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 ALARM WAS IDENTIFIED. THIS ALARM OCCURRED ON (B)(6) 2012, DURING NIGHT DRAIN 1. THIS INFORMATION MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
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 | 85 YR |