BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 522664 · Received April 28, 2004

    Report

    Report Number
    522664
    Event Type
    Other
    Date Received
    April 28, 2004
    Date of Event
    February 13, 2004
    Report Date
    February 17, 2004
    Manufacturer
    AMERIWATER, INC.
    Product Code
    FIP
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 05/28/04: THE FINAL RESULTS OF FAILURE ANALYSIS REVEALED THAT THE FAILURE RESULTED FROM AN IMPROPERLY MAINTAINED WALL (ELECTRICAL) OUTLET. THERE WAS NO FAILURE OR MALFUNCTION OF THE AMERIWATER MROS. A CAUSE ANALYSIS WAS COMPLETED BY AMERIWATER AND IT WAS DETERMINED THAT THE WALL OUTLET WAS THE ROOT CAUSE OF THE FAILURE. INFO PROVIDED TO AMERIWATER BY HOSPITAL FURTHER VALIDATED THE FINAL RESULT. AN ELECTRICIAN AT THE HOSPITAL STATED THAT THE CAUSE OF THE WALL OUTLET FAILURE WAS A "LOOSE CONNECTION" AT THE WALL OUTLET (THE PLUG NOT FITTING TIGHTLY IN THE OUTLET). THE LOOSE CONNECTION AT THE WALL OUTLET LEAD TO INCREASED ELECTRICAL RESISTANCE - GENERATING HEAT AS A RESULT. THE PROBABLE CAUSE OF THE LOOSE CONNECTION WAS NORMAL WEAR OF THE OUTLET RESULTING FROM CONNECTING AND DISCONNECTING OF POWER CORDS. PROPER MAINTENANCE OF THE OUTLET MAY HAVE PREVENTED THE OUTLET FROM FAILING. THE FAILURE AT THE WALL OUTLET CAUSED DAMAGE TO THE MROS LINE CORD PLUG CONNECTED TO THE OUTLET. THERE WAS NO FAILURE OR MALFUNCTION OF THE MROS SYSTEM. THE MROS SYSTEM WAS REMOVED FROM SERVICE AND THE DAMAGED LINE CORD REPLACED AN AMERIWATER DEALER. THE MROS WAS SAFETY TESTED BY THE AMERIWATER DEALER AS WELL AS THE BIOMED DEPARTMENT AT HOSPITAL. THE SAFETY TESTS SHOWED THAT THE MROS SYSTEM WAS OPERATING WITHIN THE SAFETY SPECIFICATIONS AS DEFINED IN ANSI/AAMI ESI-1993 REQUIREMENTS FOR NON-PATIENT CONTACT ENCLOSURES (LESS THAN 500 MICRO-AMPERE GROUND LEAKAGE). THE AMP DRAW FOR THE MROS IS WITHIN AMERIWATER SPECIFICATIONS (LESS THAN 17 AMPS). THE MROS HAS BEEN RETURNED TO SERVICE AT HOSPITAL AND HAS EXHIBITED NO EVIDENCE OF FAILURE OR MALFUNCTION. THE AMERIWATER DEALER PERFORMS MONTHLY INSPECTIONS AND MAINTENANCE OF THE MROS SYSTEM AT HOSPITAL, AND HAS NOTED NO NONCONFORMITIES WITH THE MROS 97108 IN FOLLOW UP INSPECTIONS OF THE SYSTEM.

    Description of Event or Problem · 1

    A PATIENT WAS RECEIVING DIALYSIS THERAPY. THE POWER PLUG TO THE REVERSE OSMOSIS UNIT HAD A MISSING GROUND PIN AND A LOOSE NEUTRAL PIN THAT WAS NOT NOTED BY THE NURSE. AFTER 45 MINUTES OF THERAPY THE NURSE NOTICED A 4 INCH BLACK DISCOLORATION ON THE WALL ABOVE THE OUTLET. THE NURSE UNPLUGGED THE UNIT AND THE PATIENT WAS REMOVED TO ANOTHER ROOM WITH DIFFERENT UNITS FOR THERAPY. THE OUTLET FIRE DID NOT REQUIRE EXTINGUISHING AND THE PATIENT TREATMENT WAS DISRUPTED. THE UNIT HAD BEEN MAINTAINED THE PREVIOUS DAY BY A THIRD PARTY CONTRACTOR WHO DID NOT NOTE ANY PLUG DEFECTS. THE UNIT WAS REMOVED FROM SERVICE, THE POWER PLUG REPLACED AND TESTED BY THE CONTRACTOR. THE UNIT WAS RETURNED TO THE HOSP, SAFETY TESTED BY BIOMED AND RETURNED TO SERVICE. THE POWER PLUG MAY HAVE BEEN DAMAGED FROM SOMETHING RUNNING OVER THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * REVERSE OSMOSIS MACHINE FIP AMERIWATER, INC. MROS *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other