FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS GERMAN SET
MDR report key: 2231591
·
Received August 24, 2011
Report
- Report Number
- 1722028-2011-00298
- Event Type
- Other
- Date Received
- August 24, 2011
- Date of Event
- June 27, 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 DISPOSABLE IS NOT AVAILABLE FOR INVESTIGATION. THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION THAT HAS 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 | 02T2109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |