FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM
MDR report key: 2860782
·
Received December 5, 2012
Report
- Report Number
- 1828100-2012-01591
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE UNIT WAS RECEIVED IN-HOUSE AND AS CLEANED AND DISINFECTED. THE SERVICE REPAIR TECHNICIAN (SRT) PERFORMED THE TWO YEAR EPGS RECONDITIONING ON THIS UNIT AND WILL REPLACED THE DIE-CUT RUBBER PAD AT THAT TIME. THE PRODUCT WILL BE BROUGHT TO MANUFACTURES SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. IF ADDITIONAL INFORMATION 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 TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE DIE-CUT RUBBER PAD ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) HAD BLOOD ON IT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |