BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3072587 · Received April 18, 2013

    Report

    Report Number
    1828100-2013-00365
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 29, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CUSTOMER GOT AN ALARM AND THE RESERVOIR WAS NOT EMPTY. THE CUSTOMER USED MORE GEL AND THEY WERE USING THE UNIT FOR SURGERY. DURING BYPASS, THE UNIT MALFUNCTIONED AGAIN. THEY RESET THE ALARM AND CHANGED OUT THE LEVEL SENSOR. 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 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167320 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195274

    Patients

    Seq Age Sex Outcome Treatment
    1