BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22286778 · Received June 18, 2025

    Report

    Report Number
    2521402-2025-00102
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 26, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046955674992
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). THREE UNUSED AND TWO USED SAMPLES WERE PROVIDED FOR EVALUATION. UPON EVALUATION OF THE UNUSED RETURNED SAMPLES, NO VISUAL DEFECTS WERE OBSERVED. LEAKAGE TESTING WAS PERFORMED FOLLOWING DESIGN INPUT REQUIREMENTS BY CREATING A CLOSED SYSTEM BETWEEN THE ARTERIAL AND VENOUS PORTION OF THE SETS AND TESTING THEM UTILIZING AIR UNDER WATER. NO LEAKAGE WAS IDENTIFIED. FURTHERMORE, THE SAMPLES WERE EVALUATED FOR OCCLUSION, AND NO OCCLUSIONS OR BLOCKAGES WERE IDENTIFIED. THE RETURNED USED SAMPLES UNDERWENT A VISUAL INSPECTION, AND NO VISUAL DEFECTS WERE IDENTIFIED. THE SAMPLES WERE SUBJECTED TO THE LEAK TEST. ONE OUT OF TWO FAILED LEAKAGE AT THE VENOUS POD. THE SAMPLES WERE EVALUATED FOR OCCLUSION, AND ONE OUT OF TWO FAILED OCCLUSIONS AT HEPARIN LINE OF THE ARTERIAL SET. THE REPORTED ISSUES WERE CONFIRMED. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH NO FLOW/ OCCLUSION OF THE ARTERIAL HEPARIN TUBING ID. 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: EVENT 5: REPORTER STATED THAT THERE WAS ANOTHER OCCURRENCE OF THE BUBBLE RUPTURING. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748376 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. 0061996285 04046955674992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown