FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4202552
·
Received September 18, 2014
Report
- Report Number
- 1828100-2014-00757
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- 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
Description of Event or Problem · 1
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT AFTER ABOUT THIRTY MINUTES OF OPERATION, THE ULTRASONIC AIR SENSOR (UAS) ALARMED (DETECTED AIR) EVEN THOUGH NO AIR WAS PRESENT. THIS IS CONSIDERED AN "OUT OF BOX" FAILURE. THIS WAS OBSERVED DURING A LABORATORY STUDY TO COMPARE BUBBLE SIZE DETECTION IN AIR VERSUS BLOOD. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580878 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (HEART LUNG CONSOLE) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 5773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |