BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX

    MDR report key: 10786103 · Received November 4, 2020

    Report

    Report Number
    1641965-2020-00020
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 21, 2020
    Report Date
    December 14, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    UDI-DI
    04046955048502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). BASED ON THE INFORMATION PROVIDED BY THE USER, THE SPIKE CHANGE WAS DONE INDEPENDENT OF THE APEX SOFTWARE. THE USER SHOULD ALWAYS ENSURE THE SPIKE SELECTED BY THE SYSTEM IS THE SPIKE BEING USED ON THE SOURCE CONTAINER. FAILURE TO DO SO CAN RESULT IN INACCURATE DISPENSES. IN SOME CASES, OCCLUSIONS, BUBBLES OR FINAL WEIGHT VARIANCES MAY CAUSE THE BAG TO FAIL IF THE INCORRECT SPIKE IS USED, BUT NOT ALL OF THE TIME. THERE ARE SETTINGS IN THE SYSTEM WHERE A PHARMACIST CAN CHECK AND APPROVE THE SETUP ("REQUIRE SETUP APPROVAL") AND WHERE A PHARMACIST CAN PERFORM THE PRIMING OF AN INGREDIENT ON SETUP ("REQUIRE PHARMACIST PRIMING"). THESE ARE FURTHER MITIGATIONS TO ALLOW FOR CATCHING ISSUES RELATED TO INCORRECT SPIKE TYPE SELECTION/USAGE. 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 PER REPORTED BY THE USER FACILITY: A LARGER VOLUME OF THE CONCENTRATED SODIUM CHLORIDE WAS NEEDED THAN NORMAL. A VACUUM WAS CREATED WHILE USING THE MINISPIKE ON A GLASS VIAL. THE USER CHANGED TO A VENTED SPIKE, BUT DID NOT CHANGE THE SETTING ON THE COMPOUNDER SOFTWARE. ALL OF THE BAGS WERE LOCATED AND SCRAPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251008 APEX COMPOUNDER NEP B. BRAUN MEDICAL INC. AX1000 04046955048502

    Patients

    Seq Age Sex Outcome Treatment
    1