BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22641650 · Received July 29, 2025

    Report

    Report Number
    2521402-2025-00262
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Report Date
    January 22, 2026
    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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). A TOTAL OF NINE SAMPLES WERE RETURNED FOR EVALUATION. ALL SAMPLES UNDERWENT VISUAL INSPECTION, AND NO DEFECTS WERE OBSERVED. A SUBSET OF THE SAMPLES WAS SUBSEQUENTLY SUBJECTED TO LEAK TESTING, DURING WHICH FIVE SAMPLES DID NOT MEET LEAKAGE REQUIREMENTS AT THE BLUE PATIENT CONNECTOR, AND ONE ALSO DID NOT MEET REQUIREMENTS AT THE RED PATIENT CONNECTOR. 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 THE 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: BLOOD LINES ARE LEAKING FROM THE ARTERIAL CREATING AIR BUBBLES. CUSTOMER REPORTED THAT AN ABUNDANCE OF THIS LOT FAILED THAT THERE ARE MICRO BUBBLES WHICH ARE MAKING THE MACHINE ALARM. SHE STATED THAT THE STAFF INFORMED HER THAT THE RED PLASTIC PORT ON THESE DEVICES ARE SHINY RED, AND IT IS USUALLY MATTE IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549774 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500203 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown