BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 5700339 · Received June 2, 2016

    Report

    Report Number
    MW5062658
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 4, 2016
    Report Date
    June 1, 2016
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. NR# (B)(4), INTRA-AORTIC BALLOON PUMP COUNTERPULSATION, BALLOON PUMP HAD NO ARTERIAL WAVEFORM, UNABLE TO FLUSH, UNABLE TO ASPIRATE BLOOD FROM IABP, IABP PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348629 ARROW INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL 7.5/40CC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization