BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE

    MDR report key: 2221727 · Received August 12, 2011

    Report

    Report Number
    2221727
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    May 19, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON PUMP WAS ON PATIENT AND IT ALARMED INDICATING THE WATER TRAP WAS FULL. ON INSPECTION, THE WATER TRAP WAS EMPTY. PUMP WAS ALSO ALARMING THE ARTERIAL PRESSURE (AP) WAS DISCONNECTED, BUT ALL CABLES AND LINES WERE CONNECTED APPROPRIATELY. THE PRESSURE WAVEFORM WAS NOT SHOWING UP ON THE PUMP. THE BALLOON PUMP WAS STILL PUMPING, JUST NOT SHOWING THE WAVEFORM. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE PUMP, INTRA-AORTIC BALLOON DSP ARROW INTERNATIONAL, INC. AUTOCAT2 WAVE *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR