FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3060628
·
Received April 5, 2013
Report
- Report Number
- 1828100-2013-00328
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 18, 2013
- 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
PER THE SUBSIDIARY MANUFACTURING ENGINEERING CENTER (MEC) , THEY CONFIRMED THE DEVICE FUNCTIONED NORMALLY. SOFTWARE DATA LOGS WERE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, "LOW OXYGEN SUPPLY PRESSURE" AND 'HIGH OXYGEN SUPPLY PRESSURE' ALARMS OCCURRED REPEATEDLY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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 |
|---|---|---|---|---|---|---|---|
| 139925 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |