FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1191936
·
Received October 1, 2008
Report
- Report Number
- 1828100-2008-00467
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 3, 2008
- Report Date
- October 1, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TOUCH PANEL OF THE CENTRAL CONTROL MONITOR OF THE HEART LUNG CONSOLE DID NOT FUNCTION AS EXPECTED. CONTROL OF PUMPS AND SAFETY SENSORS REMAINED AVAILABLE THROUGH REDUNDANT LOCAL CONTROLS. THERE WAS NO ADVERSE CONSEQUENCE TO THE 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 MONITOR | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |