FDA Adverse Event
Malfunction
Summary report: N
TERUMO PERFUSION SYSTEM 8000
MDR report key: 3831958
·
Received March 7, 2014
Report
- Report Number
- 1828100-2014-00141
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- February 13, 2014
- Report Date
- February 13, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K915183
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. TROUBLESHOOTING BY THE FIELD SERVICE REPRESENTATIVE (FSR) DETERMINED THE PROBLEM WAS IN THE AIR DETECT BOARD OF THE SAFETY MONITOR.
Description of Event or Problem · 1
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE AIR BUBBLE DETECT FAILED BY CONSTANTLY BEING IN ALARM STATE. UNIT IS USED FOR ANIMAL RESEARCH - "NOT FOR HUMAN USE." SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138995 | TERUMO PERFUSION SYSTEM 8000 | 8K | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 16404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |