BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCE PERFUSION SYSTEM 1

    MDR report key: 2961543 · Received February 11, 2013

    Report

    Report Number
    1828100-2013-00122
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO MDR #1828100-2013-00115.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE FLOW READING WERE FLUCTUATING. THE ISSUE WAS INTERMITTENT AND THE PERFUSIONIST WAS ABLE TO FINISH THE CASE WITH THE UNIT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60097 TERUMO ADVANCE PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 802018

    Patients

    Seq Age Sex Outcome Treatment
    1