BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 11889036 · Received May 26, 2021

    Report

    Report Number
    2521402-2021-00024
    Event Type
    Death
    Date Received
    May 26, 2021
    Date of Event
    April 16, 2021
    Report Date
    August 18, 2021
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FJK
    UDI-DI
    04046964367786
    PMA / PMN Number
    K080807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR SL-2010M2096, LOT 10154005, WAS PERFORMED AND NO QUALITY ISSUES OCCURRED DURING THE MANUFACTURING PROCESS OF THIS LOT RELATED TO THE REPORTED EVENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. 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 · 1

    AS REPORTED BY USER FACILITY: THE VENOUS LINE DETACHED FROM THE CATHETER TWO (2) HOURS INTO TREATMENT CAUSING SIGNIFICANT BLOOD LOSS OF 500+ ML. PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID PASS AWAY SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785168 HEMODIALYSIS BLOODLINES BLOOD TUBING SETS FJK B. BRAUN MEDICAL INC SL-2010M2096 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H