FDA Adverse Event
Malfunction
Summary report: N
TRIMA ACCEL PLT, PLS GERMAN SET
MDR report key: 2223310
·
Received August 15, 2011
Report
- Report Number
- 1722028-2011-00273
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 19, 2011
- Manufacturer
- CARIDIAN BCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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
THE CUSTOMER REPORTED ALLEGED FILTER FAILURE AND LRS FAILURE RESULTING IN AN ELEVATED WBC COUNT DURING A PLATELET PROCEDURE. THE PT'S INFO AND OUTCOME IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET WILL NOT BE RETURNED. THIS REPORT IS BEING FILED DUE TO A 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 | CARIDIAN BCT | 04T4114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |