BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL ACID CONCENTRATE, CA2.5 K3.0, 1 GALLON

    MDR report key: 19905436 · Received August 2, 2024

    Report

    Report Number
    MW5157962
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDIVATORS INC
    Product Code
    FKQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DIALYSATE SOLUTIONS ARE IN JUGS. THE JUGS THAT CONTAIN 2 GRAMS OF POTASSIUM AND 3 GRAMS OF POTASSIUM HAVE THE SAME COLOR AND STYLE OF LABEL EXCEPT FOR THE 2 AND THE 3. ATTACHED YOU WILL FIND A PICTURE OF THE TWO JUGS OF ACID SOLUTION WITH THE SAME LABEL EXCEPT FOR THE K AMOUNT ADDED. YOU MAY USE MY NAME AND ADDRESS. SUGGESTION WOULD BE TO HAVE DIFFERENT COLOR LABELS TO DIFFERENTIATE THE 2 GM VERSUS 3 GM JUGS. (B)(6). SUBMISSION ID: (B)(4). REFERENCE REPORT: MW5157961.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703026 CENTRISOL ACID CONCENTRATE, CA2.5 K3.0, 1 GALLON SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT FKQ MEDIVATORS INC 598341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown