FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3021224
·
Received March 26, 2013
Report
- Report Number
- 1416980-2013-07248
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- December 24, 2012
- Report Date
- March 9, 2013
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
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. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.
Description of Event or Problem · 1
A HIGH DRAIN ERROR 112 (NIGHT DRAIN #12) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2012 AT 11:10:29. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123578 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |