BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINNCARE HD

    MDR report key: 6447006 · Received March 30, 2017

    Report

    Report Number
    3019131-2017-00001
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 30, 2017
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    NIH
    PMA / PMN Number
    K133724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETERMINED A SHORT LENGTH OF PIPE, SUPPLYING THE BICARBONATE MIXER WITH WATER, WAS NOT FLUSHED/RINSED AFTER DISINFECTION. THIS SMALL VOLUME OF WATER CONTAINING THE CHEMICAL WAS USED IN THE PRODUCTION OF A LARGE BATCH OF BICARBONATE SOLUTION, FOR USE ON PATIENTS. NO DEVICE FAILURE. PROCEDURES FOR SYSTEM DISINFECTION/RINSING WERE NOT PROPERLY FOLLOWED. THIS COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MAR COR COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MAR COR ON (B)(6) 2017 THAT 39 DIALYSIS PATIENTS WERE POTENTIALLY EXPOSED TO LOW LEVELS OF MINNCARE HD DURING DIALYSIS. NO ADVERSE EVENTS TO PATIENTS HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228948 MINNCARE HD DISINFECTANT, SUBSYSTEM, WATER PURIFICATION NIH MAR COR PURIFICATION 841913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BETTER WATER BICARBONATE MIXER