BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 IABP SYSTEM

    MDR report key: 3931206 · Received June 2, 2014

    Report

    Report Number
    3931206
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 21, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MAQUET DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT WITH COMPLAINTS OF CHEST PAIN UNDERWENT CARDIAC CATHTERIZATION, WHICH REVEALED CORONARY ARTERY DISEASE INVOLVING THE LEFT MAIN WITH 20% STENOSIS, LEFT ANTERIOR DESCENDING (LAD) WITH 50% PROXIMAL AND MID STENOSIS, LEFT CIRCUMFLEX WITH 90% PROXIMAL STENOSIS, OBTUSE MARGINAL (OM) WITH 60% PROXIMAL STENOSIS AND THE RIGHT CORONARY ARTERY WITH 60% PROXIMAL STENOSIS. BLOOD PRESSURE WAS LOW WITH SYSTOLIC PRESSURE IN THE 80'S. THE PATIENT WAS GIVEN NEO-SYNEPHRINE AND A BALLOON PUMP WAS PLACED. NURSE HEARD BALLOON PUMP ALARM. ALARM READING "MECHANICAL FAILURE" AUTOFAIL FAILURE. ASSESSED BALLOON PUMP, SITE, AND CONNECTIONS. ATTEMPTED TO MANUALLY FILL BALLOON PUMP TO NO AVAIL. BALLOON PUMP SWITCHED TO ANOTHER. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322736 CS300 IABP SYSTEM SYSTEM, BALLOON, INTRA-AORTIC DSP MAQUET DATASCOPE CORPORATION CS300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR