BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL ACID CONCENTRATE

    MDR report key: 20480232 · Received October 18, 2024

    Report

    Report Number
    2150060-2024-00055
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FKQ
    UDI-DI
    00677964044281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STERIS IS NOT THE MANUFACTURER OF THE CENTRISOL ACID CONCENTRATE SUBJECT OF THE REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, ROCKWELL MEDICAL, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. STERIS IS SUBMITTING THIS REPORT SOLELY IN RESPONSE TO THE RECEIVED MEDWATCH. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH MW5159069 THAT "CONCERN ABOUT LOOK ALIKE LABELS FOR DIALYSIS ACID SOLUTIONS FROM OUTSET MEDICAL. THE 2K AND 3K ACID BATHS HAVE THE SAME WHITE WRITING ON OTHERWISE IDENTICAL RED BACKGROUND LABELS. IT WOULD BE EASY TO MIX UP THE SOLUTIONS DURING STORAGE AND CREATE A POSSIBLE ERROR." NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208004 CENTRISOL ACID CONCENTRATE CENTRISOL ACID CONCENTRATE FKQ MEDIVATORS INC. SB-352 (10)591951 00677964044281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown