FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1940127
·
Received December 23, 2010
Report
- Report Number
- 1828100-2010-02740
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 23, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED AN INTERMITTENT ALARM ON THE LEVEL SENSOR. THE USER REPORTED THE LEVEL MODULE STAYED GREEN DURING THE ALARM, AND THERE WAS NO ALARM INDICATION ON THE SCREEN. THE LEVEL SYSTEM WAS TURNED OFF, AND THE DEVICE WAS USED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |