FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE CYCLER-REFURBISHED
MDR report key: 1082058
·
Received July 23, 2008
Report
- Report Number
- 1423500-2008-00676
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). VISIBLE SMOKE WAS ENCOUNTERED DURING THE EVAL OF THE HOMECHOICE MACHINE. THE ROOT CAUSE WAS DETERMINED TO BE A BURNT JOINT CONNECTOR ON THE ACCOMPANYING PRINT CIRCUIT BOARD & PLUG OF THE HEATER CABLE. THE DEVICE WILL BE SENT FOR SERVICING. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE / PREVENTIVE ACTION AS APPROPRIATE.
Description of Event or Problem · 1
DURING THE EVAL OF THE UNIT, SMOKE WAS ENCOUNTERED. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE CYCLER-REFURBISHED | HOMECHOICE CYCLER | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |