FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2320447
·
Received October 14, 2011
Report
- Report Number
- 1828100-2011-03133
- Event Type
- Malfunction
- Date Received
- October 14, 2011
- Date of Event
- September 16, 2011
- Report Date
- October 14, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT THE SYSTEM DOES NOT STOP WHEN THE LID ID OPEN. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, 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 | ROLLER PUMP | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 816571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |