BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 7567166 · Received June 4, 2018

    Report

    Report Number
    9610825-2018-00094
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    April 11, 2018
    Report Date
    July 27, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    PMA / PMN Number
    K083689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 . B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE PUMP INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION, HOWEVER THE DEVICE HISTORY LOGS WERE PROVIDED BY THE USER FACILITY. THE LOG REVIEW SHOWED THAT THE CALCULATED VOLUME INFUSED VERSUS THE EXPECTED VOLUME TO BE DELIVERED WAS WITHIN SPECIFICATION. BASED ON INFORMATION FROM THE USER FACILITY, THE PUMP FUNCTIONED AS INTENDED BY RETURNING TO THE PRIMARY INFUSION ONCE THE SECONDARY INFUSION HAD COMPLETED. THE MOST LIKELY ROOT CAUSE FOR THE PATIENT RECEIVING AN UNINTENDED DOSE OF INSULIN WAS THAT INSULIN WAS SET AS THE PRIMARY INFUSION WITH FLUIDS SET AS THE SECONDARY INFUSION, INSTEAD OF THE OTHER WAY AROUND TO USE THE INSULIN ONLY AS A BOLUS. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A COPY OF THE DEVICE LOGS HAS BEEN PROVIDED TO B. BRAUN FOR REVIEW TO VERIFY THE FACILITY'S DETERMINATION THAT THIS INCIDIENT WAS NOT THE RESULT OF A PUMP MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: PATIENT RECEIVED OVER INFUSION OF INSULIN. THE PUMP WAS SET TO RUN A PRIMARY AND A SECONDARY INFUSION, AND WHEN A BOLUS OF THE FLUID INFUSION WAS GIVEN, THE PUMP ALSO ADMINISTERED A BOLUS OF THE INSULIN. ALTHOUGH NO PATIENT INJURY WAS OBSERVED, MEDICAL PERSONNEL INTERVENED WITH DEXTROSE 50%. THE FACILITY'S BIOMED DEPARTMENT EVALUATED THE PUMP AND DETERMINED THAT THE PUMP WAS WORKING CORRECTLY. THE FACILITY BELIEVES THE OVER INFUSION WAS THE RESULT OF USER ERROR, OR INCORRECT PROGRAMMING OF THE DRUG LIBRARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408705 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention