BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22769908 · Received August 11, 2025

    Report

    Report Number
    2521402-2025-00405
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 25, 2025
    Report Date
    December 4, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046964367786
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNATIONAL 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: WE RECENTLY SUBMITTED AN ISSUE THAT WE ARE HAVING WITH BLOODLINES WE RECEIVED- THE ARTERIAL LINE IS LEAKING AND CREATING AIR BUBLES. THIS WEEK WE SHIPPED OUT THE AFFECTED LOT NUMBERS FOR RETURN WITH THE LABELS PROVIDED. THIS MORNING THE TEAM ADVISED THAT THEY ARE EXPERIENCING THE SAME ISSUES WITH THE BLOODLINES FROM THE ORDER WE JUST RECEIVED. THEY SEEM TO BE HAVING ISSUES WITH THE BLOODLINES W/ THE SHINY PLASTIC CONNECTOR, WE HAVE SOME OF THE OLDER LINES WITH THE MATTE PLASTIC CONNECTOR AND THEY ARE NOT EXPERIENCING THE ISSUE WITH THE ARTERIAL LINE LEAKING AND HAVING BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904061 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500213 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown