BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (ST)

    MDR report key: 22877435 · Received August 22, 2025

    Report

    Report Number
    8010182-2025-00497
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 25, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    07332414118389
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: PRISMAFLEX ST100 SET CKT HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA (B)(4) TO DELIVER CRRT TO TREAT PATIENTS IN AN ACUTE CARE ENVIRONMENT DURING THE COVID-19 PANDEMIC. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION.VISUAL INSPECTION OF THE PHOTOS SHOWED THAT THE SET DEAERATION CHAMBER WAS CRACKED, WHICH ALLOWED THE REPORTED LEAKAGE. 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 COMPONENT DAMAGE WAS DETERMINED TO BE RELATED TO MECHANICAL SHOCK APPLIED TO THE PRODUCT DURING SHIPPING, TRANSPORT, AND/OR IMPROPER STORAGE. 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 AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DEAERATION CHAMBER 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
    2495482 PRISMAFLEX SETS (ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 25A0047 07332414118389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown