BEUDAMED
    FDA Adverse Event Summary report: N

    OSMO 23G REVERSE OSMOSIS EQUIPMENT

    MDR report key: 4193758 · Received October 22, 2014

    Report

    Report Number
    3019131-2014-00029
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K931595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS TO DELAY PATIENT TREATMENT (TO 11 PATIENTS) DUE TO LACK OF REVERSE OSMOSIS WATER. UPON INSPECTION IT WAS DISCOVERED THE PERMEATE DIVERT CONTROL BOX HAD A BLOWN FUSE. THIS CAUSED ALL PRODUCED WATER TO AUTOMATICALLY DIVERT TO DRAIN. CAUSE OF THE BLOWN FUSE IN UNKNOWN AND THE ISSUE WAS RESOLVED AFTER 30 MINUTES DELAY BY REPLACING THE FUSE. UNIT WAS PRODUCED IN 1999. 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

    CLINIC CONTACTED MAR COR TO REPORT THEIR REVERSE OSMOSIS WATER STORAGE TANK WENT DRY CAUSING A SLIGHT DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672413 OSMO 23G REVERSE OSMOSIS EQUIPMENT WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION 23G

    Patients

    Seq Age Sex Outcome Treatment
    1