TERUMO TCM II COOLING AND HEATING SYSTEM
Report
- Report Number
- 1828100-2013-00387
- Event Type
- Malfunction
- Date Received
- April 18, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- K883603
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
THIS UNIT WAS USED FOR TRAINING PURPOSES ONLY. THE UNIT WAS DISASSEMBLED AND REASSEMBLED DURING TRAINING CLASSES. THE UNIT IS CLEARLY MARKED "NOT FOR CLINICAL USE." THIS EVENT IS RELATED TO MDR # 1828100-2013-00325. THE SERVICE REPAIR TECHNICIAN (SRT) FOUND THE FUSE "F1" WAS BLOWN ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THE SRT REPLACED THE CARDIOPLEGIA (CPG) RELAY AND THE F1 FUSE. WITH THE COMPONENTS REPLACED, THE COOLER HEATER UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/ OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE COLLER HEATER UNIT WOULD NOT POWER UP. PER THE SRT, INITIALLY THE CARDIOPLEGIA (CPG) WATER SUPPLY FUNCTIONED TO SPECIFICATIONS. THEN HE NOTICED THE CARDIOPLEGIA CIRCULATION PUMP WAS STILL RUNNING AT A LOW SPEED EVEN THOUGH THE CPG MOTOR LIGHT EMITTING DIODE (LED) ON THE CONTROL PANEL HAD EXTINGUISHED. THE SRT POWERED THE COOLER HEATER OFF AND BACK ON AND IT STARTED THROUGH THE SELF-TEST SEQUENCE AND THEN WENT OFF AND WILL NOT POWER BACK ON. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167321 | TERUMO TCM II COOLING AND HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 15747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |