BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION

    MDR report key: 2553536 · Received April 24, 2012

    Report

    Report Number
    2553536
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 24, 2012
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ON AN INTRA-AORTIC BALLOON PUMP (IABP) WITH A RATIO OF 1:1 FOR FOUR (4) DAYS. AT 0920 AM THE PUMP STARTED ALARMING FOR LEAK IN SYSTEM. BLOOD LEAKING OUT IN THE IAB CATHETER. THE CATHETER CLAMPED, IABP PLACED ON STANDBY. THE PHYSICIAN REMOVED THE CATHETER AND PLACED ON A HEMOSTASIS DEVICE. NO LEAKING AROUND THE SITE; PHYSICIAN NOTED THAT BALLOON RUPTURED INSIDE. DURING EVENT, PATIENT HEMODYNAMICS STABLE. AFTER TWO HOURS, CARDIAC INDEX (CI) WAS LOWER AND PATIENT NEEDED A HIGHER DOSE OF DOPAMINE AND DOBUTAMINE INFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION CATHETER, INTRA-AORTIC BALLOON DSP DATASCOPE CORPORATION SENSATION *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR