BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22666368 · Received July 30, 2025

    Report

    Report Number
    2521402-2025-00266
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Report Date
    November 12, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046964200670
    PMA / PMN Number
    K080807
    Removal / Correction Number
    Z-0070-2026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLES WERE PROVIDED FOR EVALUATION. ALTHOUGH NO SAMPLES WERE PROVIDED, THE REPORTED EVENT IS SIMILAR TO A KNOWN ISSUE OF AIR IN LINE DURING USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. THE REPORTED ISSUE IS DUE TO A MANUFACTURING ISSUE WITH THE ARTERIAL AND VENOUS PATIENT CONNECTORS, WHICH MAY ALLOW AIR LEAKAGE RESULTING IN MICROBUBBLES IN THE LINE, WHICH COULD THUS TRIGGER AIR-IN-LINE ALARMS. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH AIR IN LINE. ADDITIONALLY, B. BRAUN MEDICAL INC. (BBMI) ISSUED A VOLUNTARY URGENT FIELD SAFETY CORRECTION FOR STREAMLINE® BLOODLINE SET FOR DIALOG+® HEMODIALYSIS SYSTEM (2521402-9/3/25-004-C [Z-0070-2026]). WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: WITH THIS LOT NUMBER, EXPIRES 4/7/28 THE ARTERIAL LINE IS GETTING A LOT OF AIR AS SOON AS IT IS HOOKED UP TO THE FISTULA OR CVC (CENTRAL VENOUS LINE). THERE ARE AIR BUBBLES AT THAT CONNECTION EVEN THOUGH THE USER IS MAKING SURE TO LOCK THE DEVICE IN. THE CONNECTION IS NOT JOINING PROPERLY. AS THE DEVICES WERE ATTACHED TO A PATIENT - NONE OF THE FAILING PRODUCT IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549778 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500204 04046964200670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown