FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS, RBC RAS SET
MDR report key: 2120485
·
Received May 27, 2011
Report
- Report Number
- 1722028-2011-00138
- Event Type
- Other
- Date Received
- May 27, 2011
- Date of Event
- January 25, 2011
- Report Date
- May 2, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK100032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED POST-COLLECTION HEMOLYSIS THAT EXCEEDED THE (B)(6) REQUIREMENT OF LESS OR EQUAL TO (B)(4). THE DISPOSABLE SET IS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. PATIENT AGE IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO THE SAFETY ALLEGATION OF HEMOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS, RBC RAS SET | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | LKN | CARIDIANBCT | TD1046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |