BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIBEROPTIX 30 CC 8 F

    MDR report key: 1282204 · Received January 7, 2009

    Report

    Report Number
    MW5009553
    Event Type
    Death
    Date Received
    January 7, 2009
    Date of Event
    December 24, 2008
    Report Date
    January 7, 2009
    Manufacturer
    ARROW INTERNATIONAL 2400
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN LATE 2008, A FEMALE CARDIAC PATIENT HAD AN ANGIOPLASTY PROCEDURE PERFORMED. DURING THE PROCEDURE, A BALLOON PUMP WAS INSERTED AT ABOUT 1300 HRS. PATIENT CODED AT 1830 IN ICU WITH SUSPECTED PULMONARY ARTERY RUPTURE/CARDIAC TAMPONADE. FOLLOWING SUCCESSFUL RESUSCITATION, THE PATIENT WAS TRANSFERRED TO RADIOLOGY FOR A CT SCAN. DURING THE CT SCAN, EKG CHANGES IDENTIFIED AND HELIUM LOSS WAS ALARMING ON THE BALLOON PUMP. BLOOD WAS ALSO IDENTIFIED IN THE GAS SHUTTLE TUBING. PATIENT CODED AND WAS PRONOUNCED AT 2030 THE SAME DAY. UPON FURTHER INSPECTION, A FRACTURE OF THE ARTERIAL FLASH HELIUM GAS LINE WAS NOTED AT THE PATIENT SUTURE PAD SITE AND SUSPECT HELIUM LOSS AT THE END OF THE BALLOON TIP MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIX 30 CC 8 F BALLOON PUMP BALLOON DSP ARROW INTERNATIONAL 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death