BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 23371682 · Received October 23, 2025

    Report

    Report Number
    8010182-2025-00683
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    November 20, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 8010182-2025-00663. ALL INFORMATION CAN BE FOUND UNDER MANUFACTURER REPORT NUMBER 8010182-2025-00663. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT 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

    AS REPORTED TO THE VANTIVE SERVICE ORGANIZATION ON 25 SEPTEMBER 2025, THE EVENT OCCURRED IN A HEALTHCARE FACILITY WITH A PRISMAFLEX SET (UNKNOWN PRODUCT CODE AND LOT NUMBER) USED IN A PRISMAFLEX MACHINES (PRODUCT CODE: 955433 AND PRODUCT SERIAL: (B)(6). THE REPORTER STATED SELF-TEST FAILURE CODE 1. THIS EVENT OCCURRED DURING USE. THERE WAS NO OTHER PRODUCT ASSOCIATED WITH THIS REPORTED EVENT. THERE WAS PATIENT INVOLVED DURING THIS REPORTED EVENT, TREATMENT WAS DISCONTINUED AND BLOOD WAS RETURNED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, SYMPTOMS OR ADVERSE EVENT OCCURRED DURING REPORTED EVENT. TROUBLESHOOTING WAS PROVIDED TO THE REPORTED OVER THE PHONE. THE INPUT PRESSURE SENSOR WAS DAMAGED DUE TO LIQUID INGRESS BECAUSE OF RUPTURED CONSUMABLE MEMBRANE. THE CUSTOMER REQUESTED THE PART TO BE MAILED. IT¿S REMOTE SERVICE; THE INFORMATION REQUIRED IS NOT AVAILABLE. IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX SET, THE REPORTER STATED "SELF-TEST FAILURE CODE 1" OCCURRED DURING USE. BLOOD WAS RETURNED TO THE PATIENT AND TREATMENT WAS DISCONTINUED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONALLY, IT WAS REPORTED THAT THE INPUT PRESSURE SENSOR WAS DAMAGED DUE TO LIQUID INGRESS BECAUSE OF A RUPTURED CONSUMABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777714 NI DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PRISMAFLEX MACHINE