BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 754860 · Received October 18, 2005

    Report

    Report Number
    1219856-2005-00252
    Event Type
    Malfunction
    Date Received
    October 18, 2005
    Date of Event
    September 25, 2005
    Report Date
    October 17, 2005
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL BIOMED EVALUATED PUMP, BUT COULD NOT DUPLICATE DIFFICULTY. THEY RESEATED ALL BOARDS AND CONNECTIONS, PERFORMED A FULL FUNCTIONAL CHECK ON UNIT AND RAN IT FOR TWO DAYS WITH NO FAULTS. ARROW FIELD SERVICE (AFS) CONSULTED WITH BIOMED AND EXPLAINED SYSTEM ERROR 2,3,4 ARE PROCESSOR A & B FAILURES RELATED TO CPU BOARD. AFS RECOMMENDED REPLACEMENT OF CPU BOARD. BIOMED FELT PUMP WAS NOW FUNCTIONING PROPERLY AND WOULD CONSULT AFS IF THERE WERE MORE PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONSOLE EXPERIENCED SYSTEM ERROR 2,3,4 ALARMS ON START UP. THEY STATED THE ALARMS OCCURRED PRIOR TO PUMPING INFORMATION SUGGESTS THAT PUMP WAS EXCHANGED DUE TO ALARMS. THERE WERE NO REPORTED PATIENT 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 INTERNATIONAL, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN