BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON

    MDR report key: 3062743 · Received April 11, 2013

    Report

    Report Number
    MW5029757
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 11, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL FEMALE PT IN THE ICU ON (B)(6) 2013 BEING TREATED FOR CARDIOGENIC SHOCK. THE PT WAS ON PRESSORS AND AN IABP. PT'S CONDITION WAS DETERIORATING AND FAMILY EXPRESSED DESIRE TO WITHDRAW LIFE SUPPORT. VERY EARLY ON THE MORNING OF (B)(6) 2013 THE IABP BEGAN TO ALARM AND STAFF NOTICED BLOOD IN THE TUBING. MACHINE READ "LEAK IN THE IAB CIRCUIT." BALLOON PUMP PLACED ON STAND-BY AND CARDIOLOGIST ORDERED THE STAFF TO PULL IAB; STAFF UNABLE TO PULL OUT IAB. FAMILY DECIDED TO WITHDRAW LIFE SUPPORT ON (B)(6) 2013 AND PT EXPIRED FOLLOWING EXTUBATION. IAB WAS REMOVED POST MORTEM BY MINOR SURGICAL PROCEDURE AT BEDSIDE. IAB WAS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154752 INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP DATASCOPE CORP 2709CE TFHCE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening