FDA Adverse Event
Malfunction
Summary report: N
INTEGRATED APO SET W/CASSETTE3-PRONG
MDR report key: 1297835
·
Received December 3, 2008
Report
- Report Number
- 1423500-2008-00963
- Event Type
- Malfunction
- Date Received
- December 3, 2008
- Date of Event
- November 6, 2008
- Report Date
- December 3, 2008
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKY
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER THE HOME PT, THE SAMPLE WAS DISCARDED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER'S TECHNICAL SVC CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) UNIT DURING DRAIN 2 OF 4. THE HOME PT (HP) BECAME DISCONNECTED DURING THERAPY. THE HP DID NOT RECONNECT. THE TECHNICAL SVC REP (TSR) HAD THE HP CAP OFF THE PT LINE. THE HP CYCLED THE POWER TO CLEAR THE ERROR 2240. THE HP WILL CONTACT THE PERITONEAL DIALYSIS NURSE TO ADVISE OF THE PT LINE BECOMING DISCONNECTED. THE HC WAS OPERATIONAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRATED APO SET W/CASSETTE3-PRONG | 78FKY | FKY | BAXTER HEALTHCARE - MOUNTAIN HOME | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |