BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2971249 · Received February 1, 2013

    Report

    Report Number
    1828100-2013-00085
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED. THE CUSTOMER REQUESTED AND FIELD SERVICE REP (SFR) TO EVALUATE THE ROLLER PUMP AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP WAS NOT OCCLUDING PROPERLY. 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
    45488 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1