BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE BICARBONATE

    MDR report key: 4741834 · Received April 30, 2015

    Report

    Report Number
    1225714-2015-02368
    Event Type
    Death
    Date Received
    April 30, 2015
    Report Date
    April 3, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AMERICAN JOURNAL OF KIDNEY DISEASE 2015. ARTICLE IN PRESS, ADRIANNA M. HUNG, MD, MPH AND RAYMOND M. HAKIM, MD, PHD. DIALYSATE AND SERUM POTASSIUM IN HEMODIALYSIS. PUBLISHED BY ELSEVIER, INC. ON BEHALF OF THE NATIONAL KIDNEY FOUNDATION. THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    AMERICAN JOURNAL KIDNEY DISEASE 2015: "A (B)(6) MAN WITH END STAGE RENAL DISEASE SECONDARY TO LONG STANDING HYPERTENSION EXPERIENCED SUDDEN CARDIAC ARREST DURING THE LAST HALF OF THE DIALYSIS TREATMENT... THE PATIENT DID N OT RESPOND TO CARDIAC RESUSCITATION MANEUVERS AND DIED." THE PATIENT'S TREATMENT LENGTH WAS 3.5 HOURS; DIALYSATE POTASSIUM CONCENTRATION, 2 MEQ/L (K2); CALCIUM CONCENTRATION, 2.5 MEQ/L; AND BICARBONATE CONCENTRATION, 39 MEQ/L (THE BICARBONATE BATH WAS FROM A CONCENTRATE MIX THAT ALSO HAD 8 MEQ/L OF ACETATE, RESULTING IN A TOTAL BUFFER OF 47 MEQ/L). HIS INTERDIALYTIC WEIGHT GAIN WAS AN AVERAGE OF 4 TO 4.2 KG. NECESSITATING AN ULTRAFILTRATION RATE OF W15 ML/KG/H TO ACHIEVE HIS DRY WEIGHT OF (B)(6) KG. HIS PHYSICAL EXAMINATION FINDINGS WERE UNREMARKABLE. HIS MEDICAL HISTORY INCLUDED LEFT VENTRICULAR HYPERTROPHY AND DIASTOLIC HEART FAILURE, WHICH HAD BEEN CONTROLLED SINCE THE INITIATION OF DIALYSIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284309 NATURALYTE BICARBONATE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death NATURALYTE 2251| OPTIFLUX 200 DIALYZER