FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2852427
·
Received November 13, 2012
Report
- Report Number
- 1828100-2012-01437
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- October 19, 2012
- Report Date
- October 19, 2012
- 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR HAD LINES ON THE SCREEN AND NO DISPLAY. THE UNIT WAS TURNED OFF AND BACK ON AGAIN AND THE LINES STILL APPEARED WITH NO DISPLAY. THE DEVICE WAS NOT CHANGED OUT AS SURGERY WAS CANCELED FOR AN UNRELATED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |