BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRO 300H

    MDR report key: 3973173 · Received August 1, 2014

    Report

    Report Number
    3019131-2014-00024
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K093608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT SOME TREATMENTS WERE DELAYED DUE TO THE LEAKING. REPLACEMENT VALVES WERE SHIPPED FOR ALL 11 MACHINES BECAUSE CUSTOMER COULD NOT IDENTIFY WHICH MACHINES WERE LEAKING. THE LEAKING PART(S) WAS A BACKFLOW PREVENTER ON THE INCOMING SUPPLY WATER TO THE PORTABLE RO MACHINES. THIS BACKFLOW PREVENTER IS NOT PART OF THE DEVICE BUT WAS INSTALLED ON THEIR INCOMING WATER LINES AT THE CUSTOMER'S REQUEST TO MEET LOCAL PLUMBING CODE REQUIREMENTS. MEASUREMENT OF THE INCOMING WATER SUPPLY SHOWED WIDE PRESSURE FLUCTUATIONS FROM 20PSI TO 60 PSI ON A ROUTINE BASIS. A BACKFLOW PREVENTER SPECIALIST IS EVALUATING TO IDENTIFY A DIFFERENT VALVE TO UTILIZE. THIS WILL BE MONITORED WITHIN MARCOR PURIFICATION COMPLAINT SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, THIS COMPLAINT WILL BE EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED MAR COR (MCP) TO REPORT THEIR PORTABLE REVERSE OSMOSIS MACHINES WERE LEAKING WITH WATER GOING INTO ADJACENT ROOMS. PATIENT TREATMENT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451282 WRO 300H WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1