BEUDAMED
    FDA Adverse Event Other Summary report: N

    POTASSIUM AND CALCIUM ELECTROLYTE POWDER PACKETS

    MDR report key: 18055396 · Received November 1, 2023

    Report

    Report Number
    MW5147612
    Event Type
    Other
    Date Received
    November 1, 2023
    Report Date
    October 25, 2023
    Manufacturer
    EDLAW PHARMACEUTICALS, INC.
    Product Code
    KPO
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN EVENT OCCURRED RELATED TO HEMODIALYSIS TREATMENT OF THE INCORRECT PATIENT IN AN INPATIENT FACILITY. THE 5 RIGHTS WERE NOT VERIFIED BY THE DIALYSIS NURSE OR BEDSIDE NURSE PRIOR TO INITIATING TREATMENT. THESE EVENTS LED TO THE WRONG PATIENT RECEIVING DIALYSIS FOR APPROXIMATELY 10 MINUTES AND THE PATIENT WHO NEEDED THE TREATMENT EMERGENTLY HAD A DELAY IN CARE. IN ADDITION, THE DIALYSIS ACID BATHING SOLUTION ARE HAND MIXED BASED OFF OF THE PRESCRIBER'S ORDERS. THIS COULD MEAN THE DIALYSIS NURSE IS ADDING MULTIPLE PACKETS OF POTASSIUM AND CALCIUM TO THE ACID BATHING SOLUTIONS WITHOUT ANY VERIFICATION THE CORRECT AMOUNT WAS ADDED. THE ABILITY TO SCAN THE DIALYSATE ACID BATH AND ELECTROLYTE ADDITIVES DOES NOT EXIST. THE MANUFACTURER OF THE ELECTROLYTE ADDITIVES ED LAW PHARMACEUTICALS) AND THE BATHING SOLUTIONS (MEDIVATORS, INC.) DOES NOT PROVIDE A BARCODE ON THE PRODUCTS TO FACILITATE HIGHER LEVEL RISK REDUCTION STRATEGIES SUCH AS BARCODED MEDICATION ADMINISTRATION REQUIRED BY LAW FOR ALL OTHER MEDICATION ADMINISTRATIONS IN INPATIENT HEALTHCARE FACILITIES. REPORT REFERENCE #MW5147611.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174243 POTASSIUM AND CALCIUM ELECTROLYTE POWDER PACKETS DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO EDLAW PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other