FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2040566
·
Received March 18, 2011
Report
- Report Number
- 1828100-2011-00632
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 18, 2011
- 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
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE QUALITY ASSURANCE TECHNICIAN REPORTED THAT THE ROLLER PUMP HAD AN INDENTATION ON THE MEMBRANE PANEL OVER THE DISPLAY. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PATIENT 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 SYSTEMS CORP. | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |