BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3072586 · Received April 18, 2013

    Report

    Report Number
    1828100-2013-00364
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 29, 2013
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) WOULD NOT CALIBRATE. THE USER BELIEVED THE OXYGEN (O2) SENSOR WAS DEFECTIVE. THE DEVICE WAS NOT CHANGED OUT, AS THEY MONITORED BLOOD GASES MANUALLY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168386 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1