FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2852268
·
Received November 12, 2012
Report
- Report Number
- 1828100-2012-01436
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 18, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AFTER SURGERY, THE PERFUSIONIST TURNED THE ROLLER PUMP OFF AND THEN BACK ON. THE DISPLAY CAME BACK UP. INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LOCAL DISPLAY ON THE ROLLER PUMP WAS BLANK WITH ONLY A LIGHT GREEN COLOR SHOWING. THE DEVICE WAS NOT CHANGED OUT AS THE OPERATOR WAS ABLE TO CONTROL THE PUMP WITH THE CENTRAL CONTROL MONITOR FOR SURGERY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |