BEUDAMED
    FDA Adverse Event Summary report: N

    CONCENTRATE FOR HEMODIALYSIS

    MDR report key: 10521 · Received December 6, 1993

    Report

    Report Number
    MW4000046
    Date Received
    December 6, 1993
    Manufacturer
    NATIONAL MEDICAL CARE
    Product Code
    LIF
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CONCENTRATE FOR HEMODIALYSIS "IN SHORT SUPPLY." 2K BATH WAS NEEDED; CENTER HAD ONLY "K" FREE AVAILABLE DUE TO PLANT MAKING IT (2K BATH) ON/OFF. FIRM'S REP TOLD RN THEY ARE INCREASING MFG QUALITY/VALIDATION STUDIES. TWO DIALYSIS PTS DIED. ONE A 54-YR-OLD MALE DIALYZED 11/30, DIED AT HIS HOME AT 12 NOON ON 12/1/93 (WITHIN 24 HRS OF TREATMENT). SECOND PT, A 63-YR-OLD FEMALE PT, HAD A CARDIAC ARREST AND DIED DURING DIALYSIS ON 11/30/93. ON 12/2/93, STATE HLTH DEPT WAS CONTACTED BY AN ANONYMOUS CALLER INFORMING THEM OF POSSIBLY THREE PTS DYING AT THIS CTR BECAUSE OF A "K" DIALYSATE BATH MIX-UP PROBLEM. STATE HLTH DEPT TOLD RPTR THAT THE CTR WAS UNABLE TO GET 2K DIALYSATE SO THE MD INSTRUCTED THE EQUIPMENT TECHS TO ADD K TO A NOK 55 GALLON DRUM TO TREAT PTS. IN SOME CONTAINERS NO MARKINGS INDICATED TO CLINICAL STAFF THAT K HAD BEEN ADDED. OF PARTICULAR CONCERN WAS OTHER CTRS AND WHAT CO MAY HAVE TOLD OTHER OR NOT TOLD THEM. THE CLINICAL STAFF INCLUDING DIALYSIS PREP TECHS WERE UNAWARE OF THE CONCENTRATE PROBLEM. A RECALL HAS NOT OCCURRED WITH PRODUCT (DECREASED AVAILABILITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRATE FOR HEMODIALYSIS LIF NATIONAL MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 *