BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAX MACHINES

    MDR report key: 23134031 · Received September 24, 2025

    Report

    Report Number
    9616240-2025-00025
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 24, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE LOG FILE ANALYSIS REVEALED THAT 6 DAYS PRIOR TO THE REPORTED EVENT, SEVERAL ALARMS DURING PRIMING PHASE OCCURRED; THE PRIMING PROCEDURE WAS COMPLETED, HOWEVER THE PATIENT WAS NOT CONNECTED, AND THE TREATMENT DID NOT START. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING PREVIOUS SERVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CONNECTING THE PATIENT TO A PRISMAX MACHINE FOR CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) THERAPY, THE DEVICE "STARTED PRIMING AGAIN INSTEAD OF STARTING THE PRESCRIBED THERAPY". THE PATIENT BECAME RESPIRATORY AND HEMODYNAMICALLY UNSTABLE. IT WAS REPORTED THAT THE CAUSE WAS DUE TO "THE MACHINE WAS RAPIDLY DRAWING BLOOD FROM THE PATIENT". ADDITIONALLY, IT WAS REPORTED THAT AIR WAS OBSERVED REENTERING THE PATIENT THROUGH THE RETURN LINE. IT WAS REPORTED THAT MEDICAL INTERVENTION INCLUDED INCREASING "NORADRENALINE FROM 0.66Y TO 0.94Y" AND "RESTART AGRIPRESSINE FROM 0Y TO 0.03Y". ADDITIONALLY,HE FIO2 SETTINGS FROM THE RESPIRATOR HAD TO BE SET AT 100% TO REACH A MINIMUM OF 92% OXYGEN SATURATION. IT WAS INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR ANOTHER INDICATION. PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614085 PRISMAX MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention BYPHOZYL| CA/MG 540/240ML/L| PRISMOCITRATE| REGIOCIT