FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 2240737
·
Received September 9, 2011
Report
- Report Number
- 1423500-2011-11945
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN; THEREFORE. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4). THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE PROBLEM WAS CONFIRMED AND THE CAUSE WAS USE ERROR.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC) PROBLEM OF THE DRAIN LINE THAT WAS SUBMERGED IN TOILET WATER. THE NURSE REPOSITIONED THE PATIENT, AND DRAINING STARTED TO INCREASE RAPIDLY. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOME CHOICE |