FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2972313
·
Received February 15, 2013
Report
- Report Number
- 1828100-2013-00206
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 23, 2013
- Report Date
- January 23, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS 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
THIS IS RELATED TO MEDWATCH REPORT 1828100-2013-00205. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDE.
Description of Event or Problem · 1
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE DRIVE BELT ON THE ROLLER BELT WAS COVERED WITH GREASE. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69590 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |