FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4093170
·
Received August 21, 2014
Report
- Report Number
- 1828100-2014-00687
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- July 17, 2014
- Report Date
- July 31, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, AFTER SYSTEM WAS POWERED ON, "LARGE ROLLER PUMP: 1 FAIL" ERROR MESSAGE WAS DISPLAYED AND ICON OF THE ROLLER PUMP DISPLAYED AND "X". AFTER REBOOT, THIS ISSUE DID NOT CANCEL. AS A RESULT, AN ALTERNATE, DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506769 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS (ROLLER PUMP) | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 801041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |