FDA Adverse Event
Malfunction
Summary report: N
TERUMO PERFUSION SYSTEM 8000
MDR report key: 2872513
·
Received December 12, 2012
Report
- Report Number
- 1828100-2012-01600
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K915183
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED COMPLAINT WAS CONFIRMED BY THE SERVICE REPAIR TECH (SRT). AFTER THE PUMP REPAIR AND PREVENTATIVE MAINTENANCE (PM), THE UNIT OPERATED TO MFR SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
THE SERVICE REPAIR TECH REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CTR, THAT BEARING FLUID HAD CONTAMINATED THE GUT SHAFT, DRIVE BELT, AND ENCODER WHEEL/PULLEY. THERE WERE NO FUNCTIONAL FAILURES. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO PERFUSION SYSTEM 8000 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 16402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |