BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE OSMOSIS SYSTEM

    MDR report key: 3611889 · Received February 7, 2014

    Report

    Report Number
    3019131-2014-00005
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    June 13, 2013
    Report Date
    February 6, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PURIFICATION BROUGHT IN AN OFFSITE ENGINEERING AND FORENSIC SERVICES COMPANY TO DETERMINE THE ROOT CAUSE OF FAILURE OF CWP PUMPS. TESTING PERFORMED: VISUALLY EXAMINED AND TOOK DIGITAL X-RAYS OF THE PUMP ASSEMBLY ELECTRICAL RISERS TO DETERMINE THE CONDITION OF THE CONNECTORS PRIOR TO DISASSEMBLY. ROOT CAUSE DETERMINED TO BE THE POWER CABLE CRIMP CONNECTION. THIS PART WAS INVOLVED IN A SERIES OF RESISTIVE HEATING EVENT, THAT COMPROMISED THE CONDUCTOR AND CONNECTOR INSULATION, WHICH EVENTUALLY LEAD TO A GROUND FAULT/SHORT. (B)(4) PURIFICATION ENGINEERING TEAM REDESIGNED THE ENTIRE ELECTRICAL ASSEMBLY AND REMOVED THE MANUAL CRIMPS. THIS DESIGN WAS THEN IMPLEMENTED IMMEDIATELY INTO MANUFACTURING PROCESS OF THE ENTIRE CENTRAL WATER PLATFORM (CWP). THERE WAS ALSO AN ANALYSIS OF THE PROBLEM POPULATION OF CWPS CURRENTLY AT FACILITY/USER LOCATIONS. REPLACED ALL MACHINES WITH THE DIRECT ISSUES UPDATES AND REPAIRS WERE MADE ACCORDINGLY PER SITE. GAMBRO WAS THE ORIGINAL DESIGNER WHICH (B)(4) PURCHASED THE RIGHTS TO MANUFACTURER FOR US. (B)(4) PURIFICATION WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    PUMP (PART OF CENTRAL WATER PLATFORM) BURNED UP, VISIBLE HEAT MARKS ON THE POWER CORD CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80245 REVERSE OSMOSIS SYSTEM CENTRAL WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1