FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2040577
·
Received March 18, 2011
Report
- Report Number
- 1828100-2011-00631
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 7, 2011
- Report Date
- March 18, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE PRESSURE TRANSDUCER MALFUNCTIONED WHICH CAUSED THE PRESSURE SENSOR CALIBRATION TO FAIL. THE USER ALSO REPORTED THAT ONE OF THE PRESSURE SENSORS WAS REMOVED, LEAVING 2 OTHER PRESSURE SENSORS. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | CABLE ASSEMBLY PRESSURE TRANSDUCER | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 806747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |