FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL PLT, PLS, RBC FRENCH SET
MDR report key: 2092900
·
Received May 5, 2011
Report
- Report Number
- 1722028-2011-00044
- Event Type
- Other
- Date Received
- May 5, 2011
- Date of Event
- February 10, 2011
- Report Date
- April 6, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK030083
- Product Problem
- 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 F/U REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
DURING A PROCEDURE, DURING SAMPLE COLLECTION, THE PUMP BODY DETACHED. BLOOD LEAKED ON THE NURSE. THE NURSE WAS NOT WILLING TO PROVIDE REQUESTED PT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL PLT, PLS, RBC FRENCH SET | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | LKN | CARIDIANBCT | 08S3113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |