BEUDAMED
    FDA Adverse Event Death Summary report: N

    GETINGE INTRA AORTIC BALLOON PUMP

    MDR report key: 19212474 · Received April 29, 2024

    Report

    Report Number
    MW5154426
    Event Type
    Death
    Date Received
    April 29, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 25, 2024
    Manufacturer
    GETINGE USA SALES LLC / DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 76 YEAR-OLD-MALE UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY THAT REQUIRED AN INTRA-AORTIC BALLOON PUMP (IABP) DUE TO CARDIOGENIC SHOCK. A GETINGE IABP WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. A TYPE B AORTIC DISSECTION WAS CONFIRMED INTRAOPERATIVELY. THE PATIENT EXPERIENCED REFRACTORY HYPOTENSION AND RISING LACTATE POSTOPERATIVELY. THE PATIENT RETURNED TO THE OPERATING ROOM FOR VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) CANNULATION. DESPITE SUPPORT ON VA-ECMO, INOTROPES, AND VASOPRESSOR WITH CONTINUOUS VENO-VENOUS HEMODIALYSIS THE PATIENT CONTINUED TO HAVE REFRACTORY SHOCK. THE PATIENT'S FAMILY OPTED FOR COMFORT CARE. THE VA-ECMO WAS DISCONTINUED AND THE PATIENT PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170942 GETINGE INTRA AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP GETINGE USA SALES LLC / DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death