BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2989937 · Received February 28, 2013

    Report

    Report Number
    1828100-2013-00203
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FIELD SVC REP (FSR), THE PUMP OCCLUDED AS IT SHOULD AND THE ROLLER-TO-ROLLER MEASURED .0008 WHICH WAS WITHIN TOLERANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP WAS BEING USED FOR CARDIOPLEGIA AND IT OCCLUDED. THE PERFUSIONIST TRIED TO RE-ADJUST AND COULD NOT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86161 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16395

    Patients

    Seq Age Sex Outcome Treatment
    1