BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3102624 · Received May 1, 2013

    Report

    Report Number
    1828100-2013-00403
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 TEMP MODULE WAS BROKEN. WIRES WERE COMING OUT OF IT, AT THE TOP NEAR WHERE THE TEMP MODULE PLUGS IN. THEY COULD NOT GET A READING ON THE MODULE AND WAS NOT WORKING CORRECTLY. THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER USED THE OTHER TWO TEMP READINGS. 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
    190073 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1