BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS 2008H

    MDR report key: 588581 · Received March 30, 2005

    Report

    Report Number
    588581
    Event Type
    Malfunction
    Date Received
    March 30, 2005
    Date of Event
    May 13, 2004
    Report Date
    March 30, 2005
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE MACHINE WAS IN A HEAT/DISINFECT MODE POST PATIENT TREATMENT. THE MACHINE STARTED TO SMOKE AND THEN SHUT OFF. AFTER CONTACTING THE MANUFACTURER, BIOMED WAS REFERRED TO THE JULY 2002 SERVICE BULLETIN 02-FHK-001 REV A POSTED ON THE WEBSITE. THE SERVICE BULLETIN WAS NOT RECEIVED BY THE HOSPITAL IN THE MAIL. THE BULLETIN NOTES THAT THE POWER CORD WIRES AND CONNECTIONS TO THE MAIN POWER SWITCH SHOULD BE INSPECTED AS PART OF THE QUARTERLY/1000 HOUR INSPECTION. INSPECTED CONDITION OF THE WIRES INCLUDE MELTED OR DISCOLORED INSULATION OR CROSSED WIRES THAT HAVE MELTED TOGETHER AT THEIR POINT OF INTERSECTION. IT IS VISUALLY EVIDENT THE POWER CORD WIRE SIZE IS SMALLER IN DIAMETER THAN THE REST OF THE WIRING WITHIN THE POWER SUPPLY THUS THE POWER CORD CANNOT HANDLE THE SAME CURRENT RATING AS THE INTERNAL POWER SUPPLY WIRING. IT IS A CONCERN THAT SERIOUS SAFETY ISSUES ARE KNOWN BY THE MANUFACTURER AND A PERIODIC PREVENTATIVE MAINTENANCE MAY NOT BE SUFFICIENT. ALSO, THE TIME SPENT ON REMOVING THE POWER SUPPLY FOR INSPECTION DURING THE PREVENTATIVE MAINTENANCE ALONG WITH THE REGULAR PROCEDURE IS UNREASONABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008H HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE NORTH AMERICA 2008H *

    Patients

    Seq Age Sex Outcome Treatment
    1 *