BEUDAMED
    FDA Adverse Event Summary report: N

    RENALYTE

    MDR report key: 26680 · Received January 5, 1995

    Report

    Report Number
    MW4000783
    Date Received
    January 5, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    KPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ON 3/9, AT 09:30 PT IS 1 1/2 HR INTO A HEMODIALYSIS SESSION AND COMPLAINS OF NAUSEA. BP 113/66, HR90. 09:40 PT IS BRIEFLY UNRESPONSIVE (3-5 SEC) 200 CC PSS BP 127/68 COMPLAINS OF CHEST PAIN, SOB. 10:15 ARREST NOTED, DIALYSIS D/C'D. CHEST PAINS CONTINUED TO UNRESPONSIVE. THE PT BECAME APNEIC AND A CODE CALL WAS PLACED. THE PT WAS ACCIDENTALLY GIVEN CALCIUM FREE DIALYSATE (2.5 MEQIL WAS ORDERED). SAMPLES OF CA GLUCONATE WERE GIVEN AND SYMPTOMS RESOLVED. "LOOK ALIKE" LABELING CONTRIBUTED TO EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *