FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3925174
·
Received July 10, 2014
Report
- Report Number
- 1416980-2014-21988
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 10, 2014
- Report Date
- June 16, 2014
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED AND THE ISSUE WAS IDENTIFIED DURING THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE UNEXPECTED HIGH UF (ULTRAFILTRATION) FOR THERAPY COMPARED TO OTHER THERAPIES. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 101 (NIGHT DRAIN #1) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2014 16:16:46. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403997 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |