BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE WATER PURIFICATION SYSTEM

    MDR report key: 8380256 · Received February 28, 2019

    Report

    Report Number
    3019131-2019-00003
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K945559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A PRIVATE PLUMBER INSTALLED A BRASS FITTING IN THE WATER LOOP OF THEIR COMPLETE WATER PURIFICATION SYSTEM WHEN SPLICING THE LOOP TOGETHER AFTER RELOCATING IT. THERE IS POTENTIAL FOR BRASS TO LEACH DOWNSTREAM THROUGH THE REVERSE OSMOSIS (RO) PATHWAY, THUS POTENTIAL FOR PATIENT EXPOSURE DURING HEMODIALYSIS TREATMENTS. IT WAS REPORTED THAT THE FACILITY RAN ONE DAY OF PATIENT TREATMENTS AFTER THE BRASS FITTING WAS INSTALLED BY THE PLUMBER. AFTER THE FACILITY'S BIOMED NOTICED THE BRASS FITTING, THEY REPORTED REPLACING THE BRASS FITTING WITH A PVC OR PEX FITTING. ANSI/AAMI 26722:2014 'WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS AND RELATED THERAPIES' SPECIFICALLY STATES THAT BRASS MATERIALS SHOULD BE AVOIDED DUE TO BEING DOCUMENTED AS BEING HAZARDOUS TO THE PATIENT. ADDITIONALLY, IF CHANGES ARE MADE AFTER INSTALLATION OF THE SYSTEM, THE FACILITY IS RESPONSIBLE FOR ENSURING APPROPRIATE MATERIALS/COMPONENTS ARE USED. WHILE THE RISK TO PATIENTS DERIVES FROM LONG-TERM CUMULATIVE TOXICITY, MAR COR PURIFICATION HAS DECIDED TO CONSERVATIVELY SUBMIT THIS REPORT DUE TO THE POTENTIAL FOR PATIENT EXPOSURE TO BRASS LEACHING INTO THE RO PATHWAY. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN THE MAR COR PURIFICATION COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PRIVATE PLUMBER INSTALLED A BRASS FITTING IN THE WATER LOOP OF THEIR COMPLETE WATER PURIFICATION SYSTEM WHEN SPLICING THE LOOP TOGETHER AFTER RELOCATING IT. THERE IS POTENTIAL FOR BRASS TO LEACH DOWNSTREAM THROUGH THE REVERSE OSMOSIS (RO) PATHWAY, THUS POTENTIAL FOR PATIENT EXPOSURE DURING HEMODIALYSIS TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173423 COMPLETE WATER PURIFICATION SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION PVC LOOP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other