BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1980018 · Received January 24, 2011

    Report

    Report Number
    1828100-2011-00223
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT UPON REMOVAL OF THE REAR COVER OF THE BASE AND DEAD PLATE FOR THE OXYGEN BLENDER, THE SMALL ALLEN SCREWS WERE OVER TORQUED AND WERE NOT ABLE TO BE REMOVED BY HAND. THE USER REPORTED A PRY BAR HAD TO BE USED ALONG WITH THE ALLEN KEY IN ORDER TO REMOVE THE SMALL SCREWS. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED UPON RECEIPT OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1