BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3832569 · Received March 27, 2014

    Report

    Report Number
    1828100-2014-00236
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 4, 2014
    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 ADHESIVE ON THE LEVEL SENSOR PAD WAS NOT WORKING PROPERLY. THIS ISSUE OCCURRED BEFORE USE AND THERE WAS NO PATIENT INVOLVEMENT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179505 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195240 145597

    Patients

    Seq Age Sex Outcome Treatment
    1