BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW/KONTRON KAAT II PLUS IABP

    MDR report key: 198852 · Received November 19, 1998

    Report

    Report Number
    1219856-1998-00234
    Event Type
    Malfunction
    Date Received
    November 19, 1998
    Report Date
    November 18, 1998
    Manufacturer
    ARROW INTERNATIONAL, 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

    IT WAS REPORTED THAT THE PUMP WAS IN USE ON A POST-OP PT WITH HEART RATE OF 123/125 BEATS PER MINUTE. IT WAS NOTICED THAT THE SCREEN AND READOUTS WERE INCORRECT, SHOWING THE "PDP" AND "PSP" TO BE THE SAME WHEN ACTUALLY THEY WERE DISTINCT. THE PT WAS TRANSFERRED TO ANOTHER PUMP WHICH EXPERIENCED THE SAME DIFFICULTY. THE PUMP CONTINUED TO BE USED WITH THIS DISCREPANCY AND THERE WERE NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW/KONTRON KAAT II PLUS IABP INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other