BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19804446 · Received July 23, 2024

    Report

    Report Number
    9610825-2024-00581
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 6, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: THROUGH VISUAL INSPECTION OF THE EQUIPMENT, NATURAL SIGNS OF USE WERE OBSERVED. BASED ON THE EQUIPMENT USAGE HISTORY, WE ANALYZED THE USAGE HISTORY OF JUNE 17, 2024. THE USER PROGRAMMED A FLOW RATE OF 250 ML/H TO BE INFUSED OVER A PERIOD OF 5 HOURS AND DID NOT PROGRAM ANY PARAMETER FOR VOLUME. THE INFUSION STARTED AT 11:44:39 AND WAS COMPLETED AT 12:44:37, SHOWING A TOTAL INFUSED VOLUME OF 242.2 ML, WHICH IS CONSISTENT WITH THE PROGRAMMING AND ACTIONS PERFORMED BY THE USER. IT WAS NOT POSSIBLE TO ELUCIDATE ANY INFUSION TIME ERROR THROUGH THE USAGE HISTORY. THE EQUIPMENT WAS SUBJECTED TO A FUNCTIONAL PERFORMANCE TEST TO VERIFY POSSIBLE INFUSION ERRORS USING THE SAME PROGRAMMING USED IN THE ADVERSE EVENT. THE FUNCTIONAL TEST RESULT SHOWED THAT THE EQUIPMENT IS FUNCTIONING CORRECTLY AND PRECISELY, AND THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    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. 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

    AS REPORTED BY B. BRAUN GLOBAL AFFILIATE: "PATIENT ADMITTED FOR IMMUNOGLOBULIN, TOTAL BAG VOLUME 250ML. MEDICATION ADMINISTERED AT 10:55 AM, ACCORDING TO TIME 50ML/H (TOTAL TIME 5H), PROGRAMMING CARRIED OUT THROUGH THE NURSING AND WITNESSED BY THE NURSE. AT AROUND 12:15 P.M., PATIENT, NURSING REQUEST, AS THE PUMP IS ALARMING. UPON ARRIVAL, NO ROOM, IT WAS FOUND THAT THE MEDICINE BAG WAS EMPTY, HOWEVER, THE THE PROGRAMMING ON THE DISPLAY WAS 50ML/H. PATIENT WELL, NO COMPLAINTS. SSVV VERIFIED, RESULTING. THE DOCTOR CALLED, EVALUATED THE PATIENT AND ADVISED TO KEEP THE PATIENT UNDER OBSERVATION FOR 1 HOUR AND RECOMMENDED PERFORM CREATININE COLLECTION ON 06/18."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935803 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown