BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER PURIFICATION SYSTEM

    MDR report key: 4180216 · Received October 17, 2014

    Report

    Report Number
    3019131-2014-00028
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K981085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THEY EXPERIENCED A HIGH CONDUCTIVITY ALARM ON THEIR CWP RO SYSTEM (PERCENT REJECTION HAS DROPPED TO (B)(4)). UPON INSPECTION, THE CLINIC FOUND THE REVERSE OSMOSIS LOOP'S PRETREATMENT DEALKALIZER SCAVENGER HEAD WAS NOT FUNCTIONING CORRECTLY. THIS ALLOWED THE CWP RO TO INTAKE SOME BRINE CAUSING THE HIGH CONDUCTIVITY ALARM AND RO WATER PRODUCTION TO SHUT DOWN. THE SCAVENGER HEAD WAS BYPASSED AND THE WATER CONDUCTIVITY BEGAN TO FALL. 16 PATENTS WERE TREATMENT DELAYED. THERE WERE NO REPORTS OF PATIENT ILLNESS OR INJURY AS A RESULT OF THIS INCIDENT. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN MAR COR PURIFICATION'S COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE REVERSE OSMOSIS LOOP'S PRETREATMENT DEALKALIZER SCAVENGER HEAD WAS NOT FUNCTIONING CORRECTLY WHICH CAUSED THE CWP RO UNIT TO ALARM DUE TO HIGH CONDUCTIVITY. PATIENTS HAD TREATMENT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662623 WATER PURIFICATION SYSTEM REVERSE OSMOSIS SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1