FDA Adverse Event
Malfunction
Summary report: N
DUAL COOLER/HEATER
MDR report key: 2040527
·
Received March 18, 2011
Report
- Report Number
- 1828100-2011-00640
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 18, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THAT THE HEATER COOLER HAD LEAKY NYLON FITTINGS. TWO OF THE FITTINGS WERE REPLACED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL COOLER/HEATER | COOLING & HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 11160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |