FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 4090245
·
Received September 15, 2014
Report
- Report Number
- 1416980-2014-31312
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- July 31, 2014
- Report Date
- August 21, 2014
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS VERIFIED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 105 (NIGHT DRAIN #5) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2014 21:50:39. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568834 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |