BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAR COR COMPLETE WATER TREATMENT SYSTEM

    MDR report key: 6034695 · Received October 17, 2016

    Report

    Report Number
    3019131-2016-00001
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 18, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K945559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR COR (MCP) TECHNICIAN ARRIVED ON A SUNDAY TO PERFORM A DIALYSIS LOOP DISINFECT SERVICE. NOTIFIED NURSES ON-SITE PRIOR TO STARTING THE DISINFECTION AND RECEIVED PERMISSION TO START THE MONTHLY DISINFECT. AFTER THE LOOP DISINFECTION AND DURING THE DIALYSIS LOOP RINSE OUT, THE MCP TECHNICIAN WAS PERFORMING A DISINFECTANT RESIDUAL CHECK OF ALL THE PATIENT ROOMS ON THE 6TH FLOOR. DURING THIS RISE OUT/RESIDUAL CHECK IT WAS DISCOVERED A DIALYSIS TECHNICIAN HAD STARTED A PATIENT ON DIALYSIS. THE DIALYSIS MACHINE WAS DISCONNECTED FROM THE WATER LOOP AND THE WATER LOOP PORT TESTED POSITIVE FOR DISINFECTANT. RINSE OUT OF THE WATER LOOP PORT WAS PERFORMED UNTIL THE RESIDUAL DISINFECTANT CHECK SHOWED NEGATIVE. THE CLINIC STAFF WAS NOTIFIED IMMEDIATELY OF THIS INCIDENT. MCP HAS SPOKEN WITH THE CLINIC AND HAS NOT BEEN NOTIFIED OF ANY PATIENT INJURY OR PATIENT REQUIRING MEDICAL ATTENTION.

    Description of Event or Problem · 1

    POTENTIAL OF EXPOSURE OF ONE DIALYSIS PATIENT TO MINNCARE. NO PATIENTS WERE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685380 MAR COR COMPLETE WATER TREATMENT SYSTEM SUBSYSTEM, WATER PURIFICATION FIP MAR COR PURIFICATION PVC LOOP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MINNCARE