BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (ST)

    MDR report key: 23144412 · Received September 25, 2025

    Report

    Report Number
    8010182-2025-00609
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO.: (B)(6). PRISMAFLEX ST150 SET 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTO DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAKAGE EVENT. 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 LEAK WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. 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 BASE OF THE FILTER OF A PRISMAFLEX ST 150 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394377 PRISMAFLEX SETS (ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 24L0016CC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown