FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 3842380
·
Received June 1, 2014
Report
- Report Number
- 1416980-2014-17605
- Event Type
- Malfunction
- Date Received
- June 1, 2014
- Date of Event
- July 31, 2013
- Report Date
- May 8, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- 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. THE HIGH DRAIN 110 (NIGHT DRAIN #10) EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED AS NOT ENOUGH EVIDENCE WAS AVAILABLE TO MAKE A DETERMINATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 110 (NIGHT DRAIN #10) ALARM WAS IDENTIFIED IN THE LOG (INCLUDES ANY STANDARD MODE THERAPY WHERE THE PATIENT DRAIN VOLUME EXCEEDS 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). THE ALARM OCCURRED ON (B)(6) 2013 07:57:05..NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320751 | HOMECHOICE PRO | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |