BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CWP

    MDR report key: 4644558 · Received March 31, 2015

    Report

    Report Number
    3019131-2015-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 31, 2015
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K974899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RO SYSTEM SHUT DOWN WHEN THE WATER INLET SOLENOID VALVE FAILED TO REMAIN OPEN. FIRE DEPARTMENT WAS CALLED DUE TO SOME SMOKE (FROM THE FAILED VALVE) IN THE WATER TREATMENT ROOM. 10 PATIENTS WERE ON DIALYSIS AT THE TIME, 6 WERE NEAR THE END OF TREATMENT AND 4 RESUMED TREATMENT AFTER THE VALVE WAS REPLACED. THE RO SYSTEM WAS REPAIRED IN APPROXIMATELY 30 MINUTES. NO PATIENT OR WORKER INJURIES WERE REPORTED. MAR COR WILL CONTINUE TO MONITOR THIS COMPLAINT WITH IN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    DIALYSIS CLINIC RECEIVED NO WATER SOURCE ALARMS AND HAD SOME SMOKE IN THE WATER TREATMENT ROOM. PATIENT TREATMENT DELAY OF APPROXIMATELY 30 MINUTES WHILE REPAIRS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211521 CWP REVERSE OSMOSIS SYSTEM FIP MAR COR PURIFICATION 101366

    Patients

    Seq Age Sex Outcome Treatment
    1