FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS, RBC SET
MDR report key: 2121953
·
Received June 1, 2011
Report
- Report Number
- 1722028-2011-00152
- Event Type
- Other
- Date Received
- June 1, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 7, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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 ALLEGES THAT THE PLATELET PRODUCT HAD AN ELEVATED WBC COUNT AND THE TRIMA ACCEL SYSTEM DID NOT FLAG THE PRODUCT TO BE COUNTED FOR WBCS. THE CUSTOMER REQUESTED THAT THE RUN DATA FILE BE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE DONOR. THE DISPOSABLE SET WAS DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS, RBC SET | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | LKN | CARIDIANBCT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |