FDA Adverse Event
Malfunction
Summary report: N
HX2 TEMPERATURE MANAGEMENT SYSTEM
MDR report key: 2982754
·
Received February 25, 2013
Report
- Report Number
- 1828100-2013-00157
- Event Type
- Malfunction
- Date Received
- February 25, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 2, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- K071521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE HEATER COOLER UNIT DISPLAYED "E03" ERROR CODE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79228 | HX2 TEMPERATURE MANAGEMENT SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 809810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |