FDA Adverse Event
Malfunction
Summary report: N
TERUMO CENTRIFUGAL SYSTEM
MDR report key: 2022998
·
Received February 24, 2011
Report
- Report Number
- 1828100-2011-00413
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWA
- PMA / PMN Number
- K950739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SVC CTR, THE QUALITY TECHNICIAN REPORTED THAT THE CENTRIFUGAL DRIVE MOTOR CONNECTOR'S HEATSHRINK COVER WAS CRACKED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CENTRIFUGAL SYSTEM | CENTRIFUGAL DRIVE MOTOR | DWA | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 164267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |