BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAX MACHINES

    MDR report key: 23586513 · Received November 18, 2025

    Report

    Report Number
    3003504604-2025-00015
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 18, 2025
    Report Date
    December 17, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    07332414124359
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE DEVICE WAS EVALUATED ON SITE BY A NON-VANTIVE QUALIFIED TECHNICIAN. INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE MACHINE WAS BACK IN SERVICE. A REVIEW OF THE MACHINE LOG FILES CONFIRMED THE MULTIPLE OCCURRENCES OF THE ALARM T1043 "LLS CHAMBER MISSING". A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET UP AND AFTER STARTING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE, MULTIPLE ALARMS WERE TRIGGERED. THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. THE PATIENT REQUIRED A BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494905 PRISMAX MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA 07332414124359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NI.