FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG
MDR report key: 693353
·
Received March 28, 2006
Report
- Report Number
- 1423500-2006-00428
- Event Type
- Malfunction
- Date Received
- March 28, 2006
- Date of Event
- February 19, 2006
- Report Date
- February 19, 2006
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE STEPSON OF THE HOME PATIENT (HP) CONTACTED BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A DISCONNECT SITUATION DURING THERAPY WHILE USING THE HOMECHOICE (HC) SYSTEM. STEPSON RELAYED TO TSR THAT HP WANTED TO END THE THERAPY AT DWELL 1 OF 4 SINCE HP HAD BECOME DISCONNECTED FROM SYSTEM DURING THERAPY. TSR ADVISED STEPSON TO CALL NURSE OR DOCTOR AND TO START THERAPY OVER WITH NWE SET OF SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG | HOMECHOICE CASSETTE | FKX | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR |