BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18414225 · Received December 28, 2023

    Report

    Report Number
    9610825-2023-00609
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 6, 2023
    Report Date
    September 24, 2024
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MECICAL INC. INTERNAL REPORT (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE DEVICE LOGS WERE NOT MADE AVAILABLE. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION OR THE DEVICE LOGS. IF THE DEVICE OR THE DEVICE LOGS DO BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE US+WIRELESS BATTERY PACK (MATERIAL # 8713051U) WAS USED TO INFUSE MEDICATION ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, A TOTAL PARENTERAL NUTRITION (TPN) INFUSION RAN DRY FOR THE SECOND DAY IN A ROW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530427 INFUSOMAT® PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG 97047178C3 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown