FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS, RBC SET
MDR report key: 2210107
·
Received August 5, 2011
Report
- Report Number
- 1722028-2011-00264
- Event Type
- Other
- Date Received
- August 5, 2011
- Date of Event
- May 10, 2011
- Report Date
- July 11, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
FIFTEEN MINUTES INTO THE PROCEDURE, THE DONOR RECEIVED A HEMATOMA. THE DONOR WAS RE-VENIPUNCTURED, BUT THE MACHINE ALARMED AFTER TEN MINUTES, SO THE OPERATOR ENDED THE PROCEDURE. PT INFO IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE IS NOT AVAILABLE TO BE RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFO PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS, RBC SET | AUTOMATED BLOOD CELL SEPARATOR | LKN | CARIDIANBCT | 12S3317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |