BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX MACHINES

    MDR report key: 24816761 · Received April 8, 2026

    Report

    Report Number
    9616026-2026-00059
    Event Type
    Death
    Date Received
    April 8, 2026
    Date of Event
    July 1, 2025
    Report Date
    May 8, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS TREATED WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX CONTROL UNIT. THE SYSTEM HAD BEEN PROGRAMMED FOR ANTICOAGULATION WITH AN EXTERNAL CONTINUOUS INFUSION PUMP ("BIC") OF CALCIUM. WITHIN APPROXIMATELY TWO HOURS AFTER INITIATION OF DIALYSIS, THE PATIENT BEGAN TO SHOW RAPID CLINICAL DETERIORATION WITH METABOLIC AND RESPIRATORY WORSENING. IT WAS REPORTED THAT AN ERROR OCCURRED IN THE PROGRAMMING OR ADMINISTRATION OF THE CITRATE ANTICOAGULANT SOLUTION, REPORTEDLY RESULTING IN CITRATE BEING INFUSED VIA A PRESSURE PUMP ON THE ARTERIAL LINE OF THE EXTRACORPOREAL CIRCUIT ('PBS') AT A RATE FOUR TO FIVE TIMES HIGHER THAN PRESCRIBED (REPORTEDLY 1,512 ML/HOUR, 3.8 MMOL). IT WAS FURTHER REPORTED THAT THE MACHINE WAS SHUT DOWN AND THE BLOOD WAS RETURNED TO THE PATIENT. APPROXIMATELY 40 MINUTES THEREAFTER, THE PATIENT REPORTEDLY DEVELOPED A SERIES OF CARDIORESPIRATORY COMPLICATIONS, INCLUDING SUPRAVENTRICULAR TACHYCARDIA, ATRIAL FIBRILLATION, EPISODES OF BRADYCARDIA, HYPOTENSION, ELECTROLYTE IMBALANCES, HYPOTHERMIA, AND COAGULATION ABNORMALITIES, REQUIRING MULTIPLE RESUSCITATION ATTEMPTS. THE PATIENT PASSED AWAY APPROXIMATELY TWELVE (12) HOURS AFTER THE DIALYSIS PROCEDURE WAS INITIATED. ACCORDING TO THE AUTOPSY REPORT, THE CAUSE OF DEATH WAS ASSOCIATED WITH PULMONARY THROMBOEMBOLISM; HOWEVER, BASED ON INFORMATION RECEIVED, IT IS UNDERSTOOD THAT THIS FINDING WILL BE FURTHER REVIEWED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120661 PRISMAFLEX MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1