FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE PRO
MDR report key: 3211170
·
Received July 8, 2013
Report
- Report Number
- 1416980-2013-17724
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- January 24, 2013
- Report Date
- June 13, 2013
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS IDENTIFIED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A HIGH DRAIN ERROR 104 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 AT 20:27:18 DURING THE PATIENT'S FOURTH NIGHT DRAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310405 | HOMECHOICE PRO | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |