FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2022992
·
Received February 24, 2011
Report
- Report Number
- 1828100-2011-00406
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE DEVICE GENERATED DIFFERENT ALARM SIGNALS. THE COMPANY REP IDENTIFIED THAT THE PROBLEM WAS WITH THE NIC BOARD AND REPLACED IT IN THE FIELD. THE PROBLEM WAS SOLVED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF 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. | 801764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |