FDA Adverse Event
Malfunction
Summary report: N
AUTOMATED PD SET W/CASSETTE4 PRONG
MDR report key: 1062194
·
Received June 13, 2008
Report
- Report Number
- 1423500-2008-00494
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 5, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED THE BAXTER TECHNICAL SVC CENTER REGARDING A SYSTEM ERROR 2240 DURING DRAIN 4/5 WHILE USING THE HOME CHOICE SYSTEM. THE HOME PT SOMEHOW GOT DISCONNECTED (TRANSFER SET AND PT LINE BECAME DISCONNECTED) AND HAD SOLUTION ALL OVER HIS BED. THE SVC REP ASSISTED TO CLEAR THE ERROR AND ADVISED THE HOME PT TO CALL THE NURSE. THE NURSE WAS CONTACTED AND STATED THAT THE HOME PT BECAME DISCONNECTED, DROPPED THE PT LINE AND CONTINUED WITH THERAPY. THE NURSE ALSO MENTIONED THAT THE PT WAS DIAGNOSED WITH PERITONITIS ON (B) (6) 2008, WHICH IS BEING DOCUMENTED UNDER COMPLAINT (B) (4). THE NURSE DECLINED TO PROVIDE FURTHER INFO FOR THE PERITONITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMATED PD SET W/CASSETTE4 PRONG | 78FKX | FKX | BAXTER HEALTHCARE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |