BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS

    MDR report key: 4940219 · Received July 24, 2015

    Report

    Report Number
    3019131-2015-00002
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 24, 2015
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K945559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL EQUIPMENT WAS FUNCTIONING CORRECTLY AND WITHIN SPECIFICATION. CLINIC PERFORMED INVESTIGATION AND SUSPECTS THE DISTRIBUTION LOOP WAS INCORRECTLY RINSED OUT BY A CLINIC TECHNICIAN AFTER DISINFECTION WITH MINNCARE. A FAILURE TO MANUALLY RUN BOTH DISTRIBUTION LOOP PUMPS DURING THE RINSE PROCESS, COULD HAVE INTRODUCED DISINFECTANT INTO THE LOOP WHEN THE PUMPS AUTOMATICALLY ALTERNATED.

    Description of Event or Problem · 1

    ON (B)(6) TWO DIALYSIS PATIENTS WERE EXPOSED TO MINNCARE. PATIENTS WERE HOSPITALIZED AND HAVE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483720 COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS REVERSE OSMOSIS WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION PVC LOOP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization