BEUDAMED
    FDA Adverse Event Summary report: N

    RENALYTE RX CA-FREE

    MDR report key: 29140 · Received October 5, 1995

    Report

    Report Number
    MW4001006
    Date Received
    October 5, 1995
    Date of Event
    March 9, 1995
    Report Date
    September 15, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AT 9:30 AM, 1 1/2 HRS INTO A HEMODIALYSIS SESSION, PT COMPLAINED OF NAUSEA. HER BLOOD PRESSURE WAS 113/66 AND HER PULSE WAS 90. AT 9:40 AM, THE PT BRIEFLY BECAME UNRESPONSIVE (3-5 SECS). SHE WAS GIVEN 200 ML NSS. HER BLOOD PRESSURE WAS 127/68. SHE COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH. AT 10:15 AM, SHE CONTINUED TO HAVE CHEST PAINS, DEVELOPED APNEA, AND BECAME UNRESPONSIVE. PT HAD CARDIAC ARREST. DIALYSIS WAS STOPPED AND A CODE WAS CALLED. THE PT WAS ACCIDENTALLY GIVEN CALCIUM FREE DIALYSATE. FIVE AMPULS OF CALCIUM GLUCONATE WERE ADMINISTERED AND THE SYMPTOMS RESOLVED. LOOK ALIKE LABELING CONTRIBUTED TO THE ERROR. THE STOCK NUMBER, WHICH IS SUPERIMPOSED ON THE LABEL OVER THE ELECTROLYTE CONTENTS, IS DIFFICULT TO SEE CLEARLY. TECHNICIANS WERE USING THE STOCK NUMBERS TO PULL THE PRODUCTS. (LABEL.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENALYTE RX CA-FREE DIALYSATE KPO COBE RENAL CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR