FDA Adverse Event
Malfunction
Summary report: N
TERUMO TCM II COOLING AND HEATING SYSTEM
MDR report key: 1900448
·
Received October 28, 2010
Report
- Report Number
- 1828100-2010-01928
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 28, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DWC
- PMA / PMN Number
- K883603
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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 SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED ON VALVE #1 THE EXPECTED BLACK CONNECTOR WAS MISSING. INSTEAD UNIT HAD THE WIRES CONNECTED TO THE VALVE WITH SPADE CONNECTORS. THE SERVICE TECHNICIAN REPORTED THAT ALTHOUGH THE VALVE FUNCTIONED PROPERLY, IT DID NOT MEET SPECIFICATIONS. THE SERVICE TECH REPLACED THE VALVE AND CABLE ASSEMBLY AS PART OF THE REPAIR. SINCE THE EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO TCM II COOLING AND HEATING SYSTEM | HEATING COOLING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP | 4415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |