FDA Adverse Event
Malfunction
Summary report: N
TRIMA ACCEL PLT, PLS, RBC TUBING SET
MDR report key: 2190724
·
Received July 29, 2011
Report
- Report Number
- 1722028-2011-00286
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 29, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN PROGRESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC COUNT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS NECESSARY. DONOR UNIT # (B)(4). THE DISPOSABLE KIT WAS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER HAD ALREADY DISCARDED IT. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS, RBC TUBING SET | AUTOMATED BLOOD CELL SEPARATOR | LKN | CARIDIANBCT | 04T3126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |