FDA Adverse Event
Malfunction
Summary report: N
TERUMO TCM II COOLING AND HEATING SYSTEM
MDR report key: 3060624
·
Received April 5, 2013
Report
- Report Number
- 1828100-2013-00325
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 18, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DWC
- PMA / PMN Number
- K883603
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE MAIN PUMP WOULD NOT OPERATE ON THE COOLER HEATER UNIT. THIS IS A TRAINING DEPARTMENT UNIT. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139582 | TERUMO TCM II COOLING AND HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEM CORP | 15747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |