BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22875431 · Received August 22, 2025

    Report

    Report Number
    2521402-2025-00592
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Report Date
    December 30, 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
    NC, 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). 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

    ACCORDING TO THE CUSTOMER: "THESE DEVICES ARE A DIFFERENT COLOR - THE GOOD ONES ARE MATTE, THESE ARE MORE CLEAR AND TRANSPARENT AND THE SCREW ON PORTION IS SHORTER THAN THE PREVIOUS VERSION. THE FAILURE RATE WAS 100% ON THESE LOTS, STAFF SAY, "SUCKS IN TOO MUCH AIR CAUSING THE LINES TO CLOT"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638351 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500204 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown