BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE #9028 WITH DEXTROSE CALCIUM

    MDR report key: 222633 · Received May 6, 1999

    Report

    Report Number
    2227731-1999-00148
    Event Type
    Death
    Date Received
    May 6, 1999
    Date of Event
    March 25, 1999
    Report Date
    April 15, 1999
    Manufacturer
    NMC MPD
    Product Code
    KPO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED USER FACILITY REPORT ON 4-15-99. REPORT WAS FILED AFTER PATIENT RECEIVED DIALYSIS TREATMENT WITH A NEW BATH. THIS WAS THE FIRST TIME THE PATIENT HAD EVER RECEIVED THIS DIALYSATE MIXTURE AND THE MIXTURE WAS RECOMMENDED BY THE PHYSICIAN DUE TO THE PATIENTS LAB RESULTS. THE DIALYSATE MIX INCLUDED NATURALYTE ACID AND CALCIUM AND POTASSIUM CHLORIDE FROM EDLAW PHARMACEUTICALS. THE CLINIC INDICATED THAT ALL THREE WERE NEW FOR THE PATIENT AND THAT THE TWO PHARMACEUTICAL PRODUCTS HAD NEVER BEEN USED BEFORE. THEY HAVE NOT REPORTED ANY OTHER INCIDENCES WITH THE NATURALYTE ACID. THE PATIENT ARRIVED FOR HIS TREATMENT LETHARGIC AND CONFUSED. AFTER 2.5 HOURS INTO THE TREATMENT THE PATIENT WAS FOUND UNRESPONSIVE. THE PATIENT WAS TRANSFERRED TO THE ICU WITH A NORMAL SINUS RHYTHM AND WAS INTUBATED- THE PATIENT EXPIRED THE NEXT DAY. THE MIXING PROCEDURE WAS REQUESTED. A COMPANION SAMPLE OF THE NATURALYTE ACID IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURALYTE #9028 WITH DEXTROSE CALCIUM CONCENTRATE KPO NMC MPD NA D9B024

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| R F80M DIALYZER, CALCIUM CHLORIDE, POTASSIUM| CHLORIDE, BAXTER 550.