BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 20683498 · Received November 14, 2024

    Report

    Report Number
    2523676-2024-01008
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Report Date
    November 22, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046955776016
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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). THIRTY- SIX UNUSED SAMPLES WERE PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLES, NO VISUAL DEFECTS WERE NOTED. THE SAMPLES UNDERWENT A LEAK TEST THE RESULTS INDICATED THAT NO LEAKAGES WERE OBSERVED ACROSS THE SAMPLES. TO REPLICATE THE AIR-IN-LINE DEFECT, THE SAMPLES WERE CONNECTED TO A WATER LINE AT ONE PSI PRESSURE TO OBSERVE IF AIR COULD BE INTRODUCED INTO THE SYSTEM DURING USE. THE TESTING CONFIRMED THAT NO AIR BUBBLES WERE OBSERVED THROUGHOUT THE EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. 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

    EVENT 3. FOUR INCIDENTS OF LEAKAGE WERE REPORTED TO B. BRAUN MEDICAL INC. INVOLVING STREAMLINE FRESENIUS FOR DAVITA (MATERIAL SL-2000M2095DA, LOT 0061937674). ACCORDING TO THE COMPLAINANT, SALINE WAS LEAKING FROM THE LINES AND AIR WAS GETTING IN WHICH CAUSED SOME MINIMAL BLOOD LOSS AS THEY WERE ABLE TO HANDLE THE SITUATION QUICKLY. THIS APPLIES TO ALL 4 INCIDENTS THEY HAD WITH THE LEAKING LINES. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168703 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. 0061937674 04046955776016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown