BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRISOL ACID CONCENTRATE

    MDR report key: 6360550 · Received February 27, 2017

    Report

    Report Number
    6360550
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    December 23, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FKQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO VERY DIFFERENT DIALYSIS SOLUTIONS (BOTH ACIDS) BUT WITH DIFFERENT INGREDIENTS HAVE SUCH SIMILAR LABELS THAT STAFF PULLED THE WRONG ITEM FROM SUPPLY. MISTAKE WAS CAUGHT BEFORE IT WAS USED, HOWEVER CONCERN THAT THE LABELS SHOULD MORE CLEARLY CONVEY THE DIFFERENCE SUCH AS DIFFERENT COLORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144201 CENTRISOL ACID CONCENTRATE SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT FKQ MEDIVATORS INC. SB-130 820319

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.