BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAAT II+:E/FE W/REC & HEL 115V

    MDR report key: 682424 · Received February 28, 2006

    Report

    Report Number
    1219856-2006-00079
    Event Type
    Malfunction
    Date Received
    February 28, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 28, 2006
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP WAS EXPERIENCING HELIUM LOSS ALARMS. CLINICIAN ADVISED THEY HAD EXCHANGED PUMP AND WERE NO LONGER GETTING ALARMS. THERE WAS NO BLOOD IN DRIVE LINE TUBING, PT WAS IN SINUS RHYTHM AND ALL CONNECTIONS WERE INTACT. AT TIME OF ALARM, PT WAS ABOUT TO HAVE EMESIS & WAS RESTLESS. PT WAS RESTING QUIETLY AND THERE WERE NO RPEORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAAT II+:E/FE W/REC & HEL 115V INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention