BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 616884 · Received June 9, 2005

    Report

    Report Number
    616884
    Event Type
    Injury
    Date Received
    June 9, 2005
    Date of Event
    May 11, 2005
    Report Date
    June 9, 2005
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IABP,INTRA AORTIC BALLOON PUMP, ALARMED BLOOD IN LINE, YET NO BLOOD WAS SEEN. THE PUMP WAS CHANGED OUT. A FEW HOURS LATER, NEW PUMP ALARMED BLOOD IN LINE, BLOOD WAS SEEN. ATTEMPTED TO REMOVE THE CATHETER A FEW HOURS AFTER THAT AND THE CATHETER BECAME STUCK PART OF THE WAY OUT. THE PATIENT WAS TAKEN TO THE OR BY THE VASCULAR SURGEON FOR REMOVAL AND REPAIR OF THE FEMORAL ARTERY. FOLLOW UP REVEALS TRAINING WAS THOUGHT TO BE A FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORPORATION * *
    2 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R