BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL PART A ACID CONCENTRATE

    MDR report key: 11699917 · Received April 21, 2021

    Report

    Report Number
    11699917
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FKQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SOLUTION USED FOR DIALYSIS TESTED HIGHLY POSITIVE FOR CHLORAMINE. 150 CASES IMPACTED, NONE REACHED PATIENT DIRECTLY, BUT 25 PATIENT'S DIALYSIS IMPACTED BY DELAY. THIS CONTAMINATION IF INFUSED WOULD CAUSE HEMOLYTIC ANEMIA WITH HIGH MORBIDITY AND MORTALITY. DIALYSATE SOLUTION POSITIVE FOR CHLORINE, SEVERAL CONTAINERS IN THE LOT NUMBER TESTED POSITIVE SO THE ENTIRE LOT NUMBER SEQUESTERED. WHEN THE MACHINES WERE CHECKED FOR BLEACH RESIDUE SHOULD HAVE TESTED NEGATIVE BUT SOME TESTED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601775 CENTRISOL PART A ACID CONCENTRATE SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT FKQ MEDIVATORS INC. 489224

    Patients

    Seq Age Sex Outcome Treatment
    1