FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE
MDR report key: 3200190
·
Received July 1, 2013
Report
- Report Number
- 1416980-2013-16935
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- January 12, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- 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 ALARM LOG. HOWEVER, THE CAUSE OF THE REPORTED ISSUE 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 101 ALARM MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE ALARM OCCURRED ON (B)(6) 2013 10:07:00 DURING THE PATIENT'S INITIAL DRAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298785 | HOMECHOICE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |