BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 12438695 · Received September 7, 2021

    Report

    Report Number
    MW5103755
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 2, 2021
    Manufacturer
    TELEFLEX LLC (NADC 2)
    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

    RIGHT FEMORAL INTRA-AORTIC BALLOON PUMP ALARMING HIGH PRESSURES AND BLOOD NOTED IN HELIUM LINE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328511 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX LLC (NADC 2) 1852100024

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other