BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARENA SPP 1 PUMP W/NIBPM

    MDR report key: 730479 · Received June 15, 2006

    Report

    Report Number
    1423500-2006-00683
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 1, 2006
    Report Date
    May 17, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER HAS OPENED CAPA RTB-CAPA-44 TO FURTHER INVESTIGATE HIGH BACTERIAL COUNT ISSUES. THIS CAPA IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    ON MAY 17, 2006, THE FACILITY CONTACTED BAXTER CUSTOMER SERVICE TO REPORT AN ARENA HEMODIALYSIS INSTRUMENT HAD A HIGH BACTERIAL COUNT. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED IN ASSOCIATION WITH THIS INCIDENT. ON MAY 17, 2006, A BAXTER FIELD SERVICE REP (FSR) WENT TOT HE FACILITY TO DISINFECT THE INCOMING WATER LINE. NO FURHTER INFO IS AVAILABLE AT THIS TIME. IF ADDL INFO BECAOMES AVAILABLE, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARENA SPP 1 PUMP W/NIBPM ARENA HEMODIALYSIS DELIVERY SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN