BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET/DATASCOPE

    MDR report key: 2512463 · Received March 1, 2012

    Report

    Report Number
    2512463
    Event Type
    Death
    Date Received
    March 1, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MAQUET GETINGE GROUP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON (B)(6) 2012, IN HYPERTENSIVE CRISIS (211/111) WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. PT UNDERWENT AORTIC VALVE REPLACEMENT AND INSERTION OF INTRA-AORTIC BALLOON PUMP ON (B)(6) 2012. IT WAS DIFFICULT TO WEAN PT FROM CARDIOPULMONARY BYPASS. UPON INITIAL SEPARATION FROM CARDIOPULMONARY BYPASS ALMOST SIMULTANEOUSLY THERE WAS NOTED TO BE AIR IN THE ASCENDING AORTIC CANNULA AND THE LOSS OF AIR ALARM SOUNDED ON THE INTRA-AORTIC BALLOON CONSOLE. BALLOON CATHETER WAS REMOVED AND LATER INSPECTED AND FOUND TO HAVE A HOLE IN THE DISTAL THIRD, THUS ALLOWING THE EGRESS OF HELIUM. PT PLACED BACK ON CARDIOPULMONARY BYPASS AND AORTIC CANNULA DE-AIRED WITH A DIFFERENT INTRA-AORTIC BALLOON CATHETER AND CONSOLE PLACED. PT WEANED SUCCESSFULLY FROM CARDIOPULMONARY BYPASS AND TAKEN TO CRITICAL CARE UNIT IN CRITICAL AND UNSTABLE CONDITION. MEDIASTINAL EXPLORATION WITH CONTROL OF POSTOPERATIVE BLEEDING AND STERNAL CLOSURE ON (B)(6) 2012. PT EXPIRED ON (B)(6) 2012 AT 1518.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET/DATASCOPE INTRAAORTIC BALLOON PUMP CATHETER 8FR DSP MAQUET GETINGE GROUP 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death CORONARY ANGIOGRAPHY| RIGHT HEART CATHETERIZATION