FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM
MDR report key: 1032230
·
Received April 21, 2008
Report
- Report Number
- 1828100-2008-00223
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- March 27, 2008
- Report Date
- April 21, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ELEVATION IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION FOR USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP POWER CABLE WAS NOT FULLY FUNCTIONAL, DUE TO A RECESSED CONNECTOR PIN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM | ROLLER PUMP | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |