FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 2842021
·
Received November 21, 2012
Report
- Report Number
- 1416980-2012-05723
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- July 28, 2012
- Report Date
- October 30, 2012
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION: 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 EVENT DETAILS LEADING TO THE IIPV EVENT WERE CUT OFF. THE CAUSE FOR THE IIPV EVENT WAS UNDETERMINED AS THERE WAS A LACK OF EVIDENCE 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 106 (NIGHT DRAIN CYCLE SIX) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2012. 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 |