BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18443401 · Received January 4, 2024

    Report

    Report Number
    9610825-2023-00673
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 13, 2023
    Report Date
    September 25, 2024
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 MEDICAL INC. INTERNAL REPORT (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION BUT THE LOGS WERE PROVIDED FOR REVIEW. LOG REVIEW SHOWS ON (B)(6) 2023 AND 8:00AM A PRIMARY SET-UP OF 10ML/HR AND 75ML AND A PIGGYBACK SET UP OF 500ML/HR AND 500ML (DL: VANC 750; TOTAL DOSE 1500MG; CONCENTRATE 750MG/250ML). AT 8:02AM NEW TOTAL TIME WAS SET TO 2 HOURS AND AT 8:06AM A PIGGYBACK INFUSION START OF 250ML/HR AND 500ML. AT 9:14AM INFUSION WAS STOPPED WITH A PIGGYBACK VOLUME INFUSED OF 283.26ML AND NO FURTHER INFUSIONS TAKING PLACE THAT DAY. AT 9:15AM STANDBY WAS ON; AT 9:30AM STANDBY WAS OFF; AT 9:33AM STANDBY WAS ON; AT 9:39 STANDBY WAS OFF THEN ON. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION. IF THE DEVICE DOES 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

    AS REPORTED BY THE USER FACILITY: PROGRAMED IT FOR A DOSAGE AND IT DELIVERED IT TWICE AS MUCH. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569998 INFUSOMAT® PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG 96978857K8 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown