FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1002575
·
Received February 8, 2008
Report
- Report Number
- 1828100-2008-00103
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 22, 2008
- Report Date
- February 8, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION FOR USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR OF THE HEART LUNG CONSOLE DID NOT DISPLAY GRAPHICS IMAGES PROPERLY. CONTROL OF PUMPS AND SAFETY SENSORS REMAINED AVAILABLE THROUGH REDUNDANT LOCAL CONTROLS. THERE WAS NO ADVERSE CONSEQUENCE 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 | HEART LUNG CONSOLE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |