FDA Adverse Event
Malfunction
Summary report: N
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
MDR report key: 1064174
·
Received June 18, 2008
Report
- Report Number
- 1423500-2008-00512
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- January 5, 2008
- Report Date
- June 6, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K012988
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). ADD'L 510(K) NUMBER: K923065. EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL IDENTIFIED DURING EVALUATION. BASED ON A REVIEW OF ALL THE DEVICE LOG DATA, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THE OVERFILL WAS INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND LAST MANUAL DRAIN NOT USED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING THERAPY ON (B) (6) 2008, A HOME PATIENT DRAINED 3068ML DURING THE INITIAL DRAIN FOLLOWING A LAST FILL VOLUME OF 2000ML. THE HOME PATIENT'S NURSE DECLINED TO PROVIDE FURTHER INFORMATION REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED | 78FKX | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |