FDA Adverse Event
Malfunction
Summary report: N
DUAL COOLER/HEATER
MDR report key: 3853216
·
Received April 3, 2014
Report
- Report Number
- 1828100-2014-00237
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 13, 2014
- Report Date
- March 13, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE REP (FSR) CONFIRMED THIS COMPLAINT. THE FSR FOUND THAT MOTOR SPEED RESISTOR "R2" WAS OPEN. HE REPLACED AND ADJUSTED THE NEW R2 FOR SPECIFICATION OF 35 OHMS. THE UNIT OPERATED TO MFR SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT RESISTOR R2 WAS RETURNED TO THE MFR FOR FURTHER EVALUATION. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
THE FIELD SERVICE REP (FSR) REPORTED THAT WHEN PERFORMING REPAIR ON UNIT FOR MDR #1828100-2014-00221, HE FOUND THAT THE NEW PUMP WOULD NOT RUN IN COOLING MODE #2. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203202 | DUAL COOLER/HEATER | SARNS DUAL COOLER/HEATER | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 11160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |