BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (ST)

    MDR report key: 22520184 · Received July 16, 2025

    Report

    Report Number
    8010182-2025-00397
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 13, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    07332414123468
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    PRISMAFLEX ST100 SET C 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, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED A LEAK FROM THE SET ACCESS PRE-PUMP POD. THIS COMPONENT 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. TWO (2) NONCONFORMANCE RECORDS HAVE BEEN OPENED TO INVESTIGATE AND 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 BLOOD LEAK WAS OBSERVED FROM THE PRESSURE SENSOR OF A PRISMAFLEX ST100 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE EVENT WAS DESCRIBED AS "JUST A LITTLE BLOOD LOSS". THE SET WAS REPLACED TO CONTINUE TREATMENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161939 PRISMAFLEX SETS (ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 24G0027CA 07332414123468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown