BEUDAMED
    FDA Adverse Event Summary report: N

    MAR COR COMPLETE WATER TREATMENT SYSTEM

    MDR report key: 3793897 · Received May 6, 2014

    Report

    Report Number
    3019131-2014-00019
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K945559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NOTIFIED MAR COR (MCP) THAT THE CARBON BEDDING IN THEIR WATER PURIFICATION SYSTEM SMELT STRONGLY OF SULFUR. THE ODOR PERMEATED THE ENTIRE CLINIC AND PATIENT TREATMENT WAS DELAYED. AFTER INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE THAT THE CUSTOMER DID NOT DO THE REQUIRED DISINFECTION PRIOR TO REBEDDING THE TANKS AS PER MCP MANUAL ME 12565 (AUTOMATIC CARBON TANK). PROPER PROCEDURE FOR DISINFECTING THE MACHINE WERE NOT BEING FOLLOWED AND THE CARBON BEDDING SHOULD BE REPLACED. TO DATE, THERE WERE NO REPORTS OF PATIENT INJURY OR OTHER ADVERSE PATIENT IMPACT; HOWEVER, DIALYSIS TREATMENT WAS DELAYED. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MCP COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    FACILITY PERSONNEL OBSERVED A STRONG SMELL OF SULFUR COMING FROM THE MCP CENTRAL WATER PLATFORM'S FILTRATION CARBON MEDIA. PATIENT TREATMENT WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270523 MAR COR COMPLETE WATER TREATMENT SYSTEM WATER PURIFICATION SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1