BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GETINGE LINEAR 7.5FR IAB CATHETER 34CC

    MDR report key: 9530133 · Received December 27, 2019

    Report

    Report Number
    MW5091933
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 6, 2019
    Manufacturer
    GETINGE GROUP, LOGISTICS AMERICA LLC
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INTRA-AORTIC BALLOON PUMP ASSESSMENT IT WAS NOTED THAT BLOOD WAS IN THE GAS LINE DUE TO A CATHETER RUPTURE. THE GAS LINE WAS DISCONNECTED FROM THE PT AND CLAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321907 GETINGE LINEAR 7.5FR IAB CATHETER 34CC INTRA-AORTIC BALLOON DSP GETINGE GROUP, LOGISTICS AMERICA LLC 44992 300003116

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention