BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (ST)

    MDR report key: 22998649 · Received September 8, 2025

    Report

    Report Number
    8010182-2025-00542
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 6, 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

    E1: INITIAL REPORTER FACILITY NAME:(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS DID NOT SHOW THE REPORTED LEAK FROM THE SET ACCESS POST-PUMP POD BUT SHOWED THAT THE "PRIME SELF-TEST (CODE 2)" ALARM WAS TRIGGERED ON THE MACHINE. THE COMPONENT AFFECTED BY THE LEAK, THE ACCESS POST-PUMP POD, IS MANUFACTURED BY A VANTIVE EXTERNAL SUPPLIER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE POD DEFECT WAS DETERMINED TO BE RELATED TO SUPPLIER MANUFACTURING, AND THE ISSUE IS BEING FURTHER INVESTIGATED. NONCONFORMANCE RECORDS HAVE BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE FILTER PRESSURE SENSOR OF A PRISMAFLEX ST100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915756 PRISMAFLEX SETS (ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 24E0061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.