BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRISOL CA 0.0, K 0.0

    MDR report key: 3645476 · Received February 20, 2014

    Report

    Report Number
    MW5034682
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MINNTECH
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAD A BIG ERROR HERE IN DIALYSIS AT 1 YESTERDAY WHEN THE STAFF GRABBED A 0 CA+ 0 K+ BATH FOR A PATIENT INSTEAD OF CA+2.5 AND K+2.0 BATH AND PATIENT EXPERIENCED THE SYMPTOMS OF SEVERE HYPOCALCEMIA. OUR STANDARD DIALYSIS BATH IS 2.5 CA+ K+2.0. OF COURSE, THE POOR LABELING AS WELL AS HUMAN ERROR ALSO CONTRIBUTED TO THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106428 CENTRISOL CA 0.0, K 0.0 DIALYSIS BATH KPO MINNTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening