FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1881161
·
Received October 1, 2010
Report
- Report Number
- 1828100-2010-01592
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- September 7, 2010
- Report Date
- October 1, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE USER REPORTED THE ROLLER PUMP GENERATED A FAILURE ERROR MESSAGE READING "MOTOR ERROR, SERVICE PUMP". NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING ROUTINE TESTING 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 | ROLLER PUMP | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |