BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G CENTRAL DIALYSIS REVERSE OSMOSIS WATER SYSTEM

    MDR report key: 4267455 · Received November 20, 2014

    Report

    Report Number
    3019131-2014-00031
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K931595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC HAD TO DELAY PATIENT TREATMENT DUE TO LOW FLOW (3.2 GPM) FOLLOWING A LOW/HIGH MEMBRANE CLEANING AND DISINFECT. SDI AND TOC TESTS WERE COMPLETED WITH NO ABNORMAL RESULTS. WATER SOFTENER IS REPORTED TO BE WORKING CORRECTLY WITH TWICE DAILY TESTING. 58 PATIENTS HAD TREATMENT DELAYED AND THE CLINIC CONFIRMED THERE WERE NO MEDICAL CONSEQUENCES RELATED TO THE DELAY. 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

    CUSTOMER HAS REPORTED LOWER FLOW RATES AND INCREASED CLEANING FREQUENCY AFTER INSTALLING NEW REVERSE OSMOSIS MEMBRANES IN THEIR CENTRAL WATER SYSTEM. THE LOW FLOW RESULTED IN THE NEED DELAY PATIENT TREATMENT WHILE WAITING FOR DI TANKS TO BE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754013 23G CENTRAL DIALYSIS REVERSE OSMOSIS WATER SYSTEM CENTRAL WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION 23G

    Patients

    Seq Age Sex Outcome Treatment
    1