FDA Adverse Event
Malfunction
Summary report: N
TERUMO TCM II COOLING AND HEATING SYSTEM
MDR report key: 3943753
·
Received April 30, 2014
Report
- Report Number
- 1828100-2014-00309
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 7, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- K883603
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT ADVISED THE USER FACILITY BIOMEDICAL ENGINEER (BIOMED) TO REPLACE THE TEE FITTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE COOLER HEATER UNIT WAS LEAKING AT THE TEE FITTING NEAR VALVE #6. PERFUSIONIST (CCP) NOTICED THE LEAK WHEN MACHINE WAS JUST SITTING IN THE PUMP ROOM. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258286 | TERUMO TCM II COOLING AND HEATING SYSTEM | TERUMO TCM II COOLING AND HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 4415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |