BEUDAMED
    FDA Adverse Event Summary report: N

    S5

    MDR report key: 2032201 · Received February 24, 2011

    Report

    Report Number
    2032201
    Date Received
    February 24, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 24, 2011
    Manufacturer
    SORIN
    Product Code
    DWB
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING OPEN HEART SURGERY AND CARIOPLEGIA SOLUTION WAS BEING ADMINISTERED BY THE PERFUSIONIST. ONE OF THE ROLLER PUMPS ON THE PERFUSION MACHINE WAS WORKING INTERMITTENTLY, THE PERFUSIONIST ATTEMPTED TO CRANK IT BY HAND. THE PERFUSIONIST THEN CHANGED THE CARDIOPLEGIA DELIVERY SYSTEM TO THE OTHER ROLLER PUMP, AND CARDIOPLEGIA SOLUTION WAS DELIVERED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 PERFUSION MACHINE DWB SORIN S5 10E02773

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CARDIAC DRUGS