FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 2781910
·
Received October 11, 2012
Report
- Report Number
- 1416980-2012-02108
- Event Type
- Malfunction
- Date Received
- October 11, 2012
- Date of Event
- July 5, 2012
- Report Date
- September 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 WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. THERE WAS NOT ENOUGH INFORMATION AVAILABLE TO MAKE A DETERMINATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.
Description of Event or Problem · 1
A HIGH DRAIN ERROR 104 (NIGHT DRAIN #4) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2012 06:16:13. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.
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 | 76 YR |