FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3012986
·
Received March 1, 2013
Report
- Report Number
- 1828100-2013-00185
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 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
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE QUALITY ASSURANCE LAB TECH REPORTED THAT DURING LAB ANALYSIS OF THE DEVICE AT THE SERVICE CENTER, A BELT SLIP ERROR OCCURRED ON THE ROLLER PUMP. UPON INSPECTION OF THE PUMP, OIL WAS OBSERVED ON THE BELT PULLEY CAUSING THE BELT SLIP. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90489 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 816571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |