FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS GERMAN SET
MDR report key: 2231596
·
Received August 24, 2011
Report
- Report Number
- 1722028-2011-00300
- Event Type
- Other
- Date Received
- August 24, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 29, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROGRESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE WBC COUNT WAS TOO HIGH AND ALLEGES A FILTER/LRS MALFUNCTION. THE PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE IS NOT AVAILABLE FOR EVALUATION. THIS REPORT IS BEING FILED TO REPORT AN ALLEGED DEVICE MALFUNCTION THAT COULD HAVE THE POTENTIAL FOR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS GERMAN SET | AUTOMATED BLOOD CELL SEPARATOR | LKN | CARIDIANBCT | 03T2110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |