BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS

    MDR report key: 3691048 · Received March 20, 2014

    Report

    Report Number
    3019131-2014-00010
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    July 31, 2013
    Report Date
    March 20, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K945559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARBON TANK HEADS SPLIT/ CRACKED CAUSING AND LEAKED WATER ALL OVER THE RO ROOM AND PATIENT DIALYSIS WAS DELAYED. MAR COR PURIFICATION SERVICE REPRESENTATIVE WENT TO FACILITY AND REPAIRED AND REPLACED BROKEN PARTS OF SYSTEM. PLEASE REFERENCE ATTACHED PICTURES. TO THIS 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. IF ADDITIONAL INFORMATION IS RECEIVED, THIS CASE WILL BE REVIEWED UPON RECEIPT.

    Description of Event or Problem · 1

    CARBON TANK HEADS THREADED CONNECTION CRACKED AND LEAKED WATER ALL OVER THE RO ROOM OF THE DIALYSIS CLINIC CAUSING DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165951 MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS WATER PURIFICATION SUBSYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1