BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4791493 · Received May 20, 2015

    Report

    Report Number
    1828100-2015-00418
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 29, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) ORDERED A REPLACEMENT UAS AND/OR LATCH AND WILL RETURN TO THE CUSTOMER SITE TO REPLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ULTRASONIC AIR SENSOR (UAS) LATCH WAS BROKEN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328169 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 H LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1