FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3227629
·
Received July 15, 2013
Report
- Report Number
- 1416980-2013-18511
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- May 6, 2013
- Report Date
- June 20, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE LOGS, BUT THE CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
A HIGH DRAIN ERROR 103 (NIGHT DRAIN THREE) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2013 06:08:42. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325525 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |