BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE STERILE XCOATED DELPHIN

    MDR report key: 4976980 · Received August 6, 2015

    Report

    Report Number
    1124841-2015-00219
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 6, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS THE CENTRIFUGAL PUMP WAS FOUND TO LEAK. APPROXIMATELY 40 MINUTES INTO A CEC PROCEDURE, BLOOD WAS NOTED DRIPPING FROM THE DEVICE. IT IS UNKNOWN AS TO HOW MUCH BLOOD WAS LOST DUE TO THIS LEAK, OR WHETHER THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519618 SINGLE STERILE XCOATED DELPHIN CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 164275X RE24

    Patients

    Seq Age Sex Outcome Treatment
    1