BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO WATER PURIFICATION SYSTEM

    MDR report key: 4282249 · Received November 26, 2014

    Report

    Report Number
    3019131-2014-00032
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K981085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE WATER SATURATION OF THE ELECTRONICS AND MAIN CWP RO CONTROL PANEL THE CUSTOMER WAS ADVISED TO REPLACE THE ENTIRE CWP RO CONTROL PANEL. PATIENTS WERE NOT ABLE TO DIALYZE UNTIL DEIONIZED WATER TANKS WERE BROUGHT ONLINE, AFTER WHICH ALL PATIENTS WERE ABLE TO BE DIALYZED. THERE WERE NO REPORTS OF PATIENT ILLNESS OR INJURY AS A RESULT OF THIS INCIDENT. MAR COR PURIFICATION WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    MAR COR PURIFICATION INSTALLED A 10 CUBIC FOOT CARBON TANK IN THE CLINIC'S PRETREATMENT PORTION OF THE REVERSE OSMOSIS WATER SYSTEM IN (B)(6) OF 2013. MCP WAS NOTIFIED ON (B)(6) 2014 THAT THE CARBON TANK FEED SIDE UNION LEAKED AND SPRAYED WATER ON THE CEILING. THE WATER WAS DEFLECTED ONTO THE TOP OF THE CLINICS CWP REVERSE OSMOSIS WATER SYSTEM CAUSING THE ELECTRONICS AND MAIN CONTROL PANEL TO BECOME WET. THIS CAUSED THE CWP TO STOP GENERATING REVERSE OSMOSIS WATER RESULTING IN THE DELAY OF PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767097 GAMBRO WATER PURIFICATION SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION 100474

    Patients

    Seq Age Sex Outcome Treatment
    1