FDA Adverse Event
Other
Summary report: N
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
MDR report key: 2121944
·
Received June 1, 2011
Report
- Report Number
- 1722028-2011-00124
- Event Type
- Other
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 6, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- BK080029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 SEVERAL PUMP MOTOR HARDWARE FAILURE ALARMS AND A CASSETTE FAILURE ALARM DURING THE SET UP FOR A PROCEDURE. THEY ARE ALSO QUESTIONING WHY THE TBV DISPLAYED WAS GREATER THAN 8L. THERE IS NO SAFETY ISSUE RELATED TO THE ALARMS DURING SET-UP. THIS REPORT IS BEING FILED DUE TO THE SAFETY ALLEGATION OF TBV DISPLAYED >8L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | LKN | CARIDIANBCT | 81000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |