BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 8955177 · Received September 3, 2019

    Report

    Report Number
    1641965-2019-00014
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 7, 2019
    Report Date
    October 9, 2019
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    NEP
    UDI-DI
    04046964801068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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). NO LOGS OR FILES WERE RETURNED FOR EVALUATION. TO DETERMINE A POTENTIAL ROOT CAUSE A COPY OF THE DATABASE OR THE PATIENT FILE IS REQUIRED AND THEREFORE THE EVENT CANNOT BE CONFIRMED. THIS IS LIKELY AN ISSUE WITH THE CUSTOMER'S SETUP OF THE DATABASE OR HOW THE PATIENT FILE (.PAT) WAS GENERATED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PER USER FACILITY: CUSTOMER REPORTED THEY HAD ADDED THE NEW SMOFLIPID TO THEIR SCDM DATABASE EARLIER IN THE DAY BUT THE COMPOUNDER WAS NOT PUMPING THE CORRECT AMOUNT FOR THE PATIENT ORDER. THE COMPOUNDER WAS PUMPING WATER INSTEAD OF THE SMOFLIPID SOLUTION. NO PATIENT INVOLVEMENT.

    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 USER FACILITY: CUSTOMER REPORTED THEY HAD ADDED THE NEW SMOFLIPID TO THEIR SCDM DATABASE EARLIER IN THE DAY BUT THE COMPOUNDER WAS NOT PUMPING THE CORRECT AMOUNT FOR THE PATIENT ORDER. THE COMPOUNDER WAS PUMPING WATER INSTEAD OF THE SMOFLIPID SOLUTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749563 APEX¿ COMPOUNDER NEP B. BRAUN MEDICAL INC 601224 04046964801068

    Patients

    Seq Age Sex Outcome Treatment
    1