BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19489072 · Received June 7, 2024

    Report

    Report Number
    9610825-2024-00458
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 24, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. INVESTIGATION: UPON VISUAL INSPECTION OF THE EQUIPMENT, NATURAL SIGNS OF USE WERE OBSERVED. THE EQUIPMENT'S OPERATIONAL HISTORY WAS EVALUATED, AND IT WAS IDENTIFIED THAT THERE WERE TWO USES IN THE DRUG LIBRARY. ADDITIONALLY, NO PROGRAMMING RECORD WAS FOUND FOR (B)(6) 2024. REGARDING THE USER-PROVIDED DATA ON PROGRAMMING, ONLY A FLOW RATE OF 3.71 ML/H ON (B)(6) 2024, WAS IDENTIFIED IN THE HISTORY. THE INFUSION OCCURRED ACCORDING TO THE PROGRAMMING AND USER ACTIONS, WHO DECIDED TO STOP THE INFUSION AT 04:50:54 ON (B)(6) 2024. THE EQUIPMENT UNDERWENT FUNCTIONAL TESTING TO VERIFY ITS OPERATION. A VOLUME OF 85.34 ML WAS PROGRAMMED WITH A FLOW RATE OF 3.71 ML/H TO BE INFUSED OVER A 23-HOUR PERIOD, AS REPORTED IN THE ADVERSE EVENT. HOWEVER, AFTER ANALYZING THE FUNCTIONAL TEST RESULTS, IT WAS EVIDENT THAT THE EQUIPMENT IS INFUSING CORRECTLY AND PRECISELY, THUS NOT CONFIRMING THE COMPLAINT. ALL INFORMATION HAS BEEN RECORDED IN A GLOBAL CUSTOMER COMPLAINTS DATABASE AND WILL BE USED FOR TREND ANALYSIS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT: ''PATIENT WITH INFUSION OF TACROLIMUS 1.7 MILLIGRAM RECONSTITUTED IN SF AND TOTAL VOLUME OF 85.34 ML OF SF, PRESCRIBED AT A RATE OF 3.71 ML PER HOUR INSTALLED AT 11:14 AM ON 25/04, NOTICED AT 7:30 PM WHICH WAS 7.9 ML/H AND THE FLOW RATE WAS THEN CHANGED TO 3.71 AS PRESCRIBED, THE CASE'S DOCTOR INFORMED, THE INFUSION WAS PAUSED AFTER THE END OF THE BAG AND A NEW SERUM LEVEL WAS COLLECTED BEFORE THE NEXT ONE. IN MITIGATION, THE EMPLOYEE WHO INSTALLED THE MEDICINE CLAIMS TO HAVE PROGRAMMED THE PUMP ACCORDING TO THE PRESCRIPTION, REQUIRING ANALYSIS OF THE EQUIPMENT TO VALIDATE THIS DATA." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326235 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown