BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 10950057 · Received December 4, 2020

    Report

    Report Number
    2521402-2020-00008
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 18, 2020
    Report Date
    March 9, 2021
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FJK
    UDI-DI
    04046964367786
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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), EVENT 1. ONE (1) BLOODLINE SET WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION IN CONJUNCTION WITH THIS COMPLAINT. THE BLOOD SET WAS VISUALLY INSPECTED AND APPEARED TO HAVE BEEN RINSED AS THERE WAS NO SEDIMENT OBSERVED IN THE LINE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR SL-2010M2096 LOT: 00754022 WAS PERFORMED AND IT INDICATED THERE WERE NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS OF THIS LOT RELATED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE REPORTED DEFECT COULD NOT BE CONFIRMED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT 1 OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND 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

    EVENT 1: AS REPORTED BY USER FACILITY: WHEN REINFUSION BLOOD TO PATIENT AT THE END OF TREATMENT SEDIMENT WAS NOTED IN THE VENOUS BLOODLINE. PATIENT WAS ASYMPTOMATIC AND NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413158 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC SL-2010M2096 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1