BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER

    MDR report key: 24337152 · Received February 13, 2026

    Report

    Report Number
    0001713747-2026-00080
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 10, 2026
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100149
    PMA / PMN Number
    K173718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE COMPLAINT COULD NOT BE CONFIRMED, AS A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT. A SAMPLE WAS NOT RETURNED. AS A LOT NUMBER OR CATALOG NUMBER WERE NOT PROVIDED, A DELIVERY HISTORY SEARCH WAS PERFORMED TO OBTAIN ALL LOT NUMBERS DELIVERED TO THE PATIENT IN THE THREE MONTHS PRIOR TO THE OCCURRENCE DATE. THERE WERE 18 LOTS DELIVERED DURING THIS TIME FRAME. A LOT HISTORY AND PRODUCTION RECORD REVIEW WERE PERFORMED ON EACH OF THE 18 IDENTIFIED LOTS. THE LOT TREND COULD NOT BE EVALUATED AS A SPECIFIC LOT NUMBER WAS NOT PROVIDED.A REVIEW OF THE PRODUCTION RECORDS WERE PERFORMED. THE PRODUCTION RECORD REVIEW SHOWED THERE WAS ONE APPROVED TEMPORARY DEVIATION NOTICE (DN) FROM TWO OF THE IDENTIFIED LOTS AND ONE LOT HAD ONE NONCONFORMANCE (NC): IMPROPER CONTAINMENT RESULTING IN REWORK 308-2025. THEY ARE UNRELATED TO THE REPORTED COMPLAINT EVENT. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION IN THE MANUFACTURING PROCESS RELATED TO THE COMPLAINT EVENT. THIS INCLUDES NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION THAT WAS POTENTIALLY RELATED TO THE COMPLAINT. THE REPORTED LOT NUMBER PASSED PYROGEN TESTING, WAS WITHIN STERILIZATION DOSAGE PARAMETERS AND PASSED ALL RELEASE CRITERIA..CONTINUOUS IMPROVEMENT IS OF THE UTMOST IMPORTANCE TO FRESENIUS MEDICAL CARE AS WE STRIVE TO PROVIDE DIALYSIS PRODUCTS OF THE HIGHEST QUALITY TO OUR PATIENTS. REPORTS OF LEAKING PRODUCT ARE INVESTIGATED BOTH INDIVIDUALLY AS COMPLAINTS, AS WELL AS VIA THE NC/CAPA PROGRAM IN ORDER TO ASSESS AND IMPROVE OUR PRODUCTS AND PROCESSES. CAPAS FOR VISION SYSTEMS AND BLOOD LEAK REDUCTION ARE RECENT EXAMPLES OF LEAK RELATED INVESTIGATIONS DIRECTED AT AN OVERALL REDUCTION IN DIALYZER LEAKS.

    Description of Event or Problem · 0

    A SUPPLIES MANAGER REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH A HEMODIALYSIS (HD) TREATMENT. THERE WAS NO HARM , INTERVENTION OR ADVERSE EVENT REPORTED IN THE INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO DATA WAS PROVIDED. A DIALYZER HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A SUPPLIES MANAGER REPORTED A DIALYZER BLOOD LEAK ASSOCIATED WITH A HEMODIALYSIS (HD) TREATMENT. THERE WAS NO HARM , INTERVENTION OR ADVERSE EVENT REPORTED IN THE INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO DATA WAS PROVIDED. A DIALYZER HAS NOT BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391228 DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 00840861100149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown