FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1980035
·
Received January 24, 2011
Report
- Report Number
- 1828100-2011-00225
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- December 23, 2010
- Report Date
- January 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT UPON REMOVAL OF THE REAR COVER OF THE BASE, THE SMALL ALLEN SCREWS HEADS WERE FOUND TO BE STRIPPED FROM THE FACTORY AND HAD TO BE DRILLED OUT. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED UPON RECEIPT OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP | 801763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |