FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
MDR report key: 1230756
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00114
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- February 8, 2007
- Report Date
- February 8, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2007, CAPD TRANSFER SET, 2007, DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNKNOWN), 2007.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE WITH ENDING THERAPY BECAUSE FLUID WAS LEAKING FROM THE PATIENT LINE. PER THE HOME PATIENT, A CAT CHEWED THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THERAPY. THERE WERE NO ALARMS. HOME PATIENT WILL START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HOME PATIENT TO INFORM THE NURSE ABOUT THIS INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG | HOMECHOICE CASSETTE | FKX | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | REFER TO H.10 |