BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22922673 · Received August 29, 2025

    Report

    Report Number
    2521402-2025-00638
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Report Date
    December 19, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNATIONAL REPORT NUMBER (B)(4). TWO (2) PHOTOGRAPHS WERE SUBMITTED TO THE MANUFACTURER. BASED ON THE INFORMATION PROVIDED FOR THE COMPLAINT, 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: MY STAFF BROUGHT TO MY ATTENTION THAT SOME, NOT ALL OF THE TUBING FROM LOT A2500210, REF SL-2010M2096 IS HAVING MICRO BUBBLES IN THE ARTERIAL LINE DURING TREATMENT. NO INTERVENTION WAS HELPFUL. STAFF STATE CONNECTS WERE TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865474 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500210 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown