BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18161116 · Received November 17, 2023

    Report

    Report Number
    9610825-2023-00531
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 12, 2023
    Report Date
    April 26, 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 MEDICAL INTERNAL REPORT NUMBER 400624964. [ANALYSIS OF USE HISTORY]: THE 350ML/H SCHEDULE WAS NOT FOUND IN THE USAGE HISTORY ON 10/12/2023. NO 350ML/H SCHEDULE WAS ALSO RECORDED IN THE ENTIRE RECORDED HISTORY FROM MAY TO OCTOBER 2023. REGARDING THE TIME OF 30 MINUTES, THE LAST RECORDED SCHEDULE WAS ON 10/14/2023. THE RECORD SHOWS THAT THE INFUSION OCCURRED ACCORDING TO THE SCHEDULED SCHEDULE WITH NO EVIDENCE OF AN INFUSION ERROR. [FUNCTIONAL ANALYSIS]: TO CHECK THE PERFORMANCE OF THE EQUIPMENT, WE PERFORM INFUSION WITH A SCHEDULE SIMILAR TO THE ONE WE ANALYZED IN THE HISTORY. PROGRAMMED FLOW: 585.4ML/H PROGRAMMED VOLUME: 292.7ML RESULTING TIME: 30MIN. INFUSED VOLUME: 300ML ERROR: +2.50% INFUSION TIME: 29MIN59 ERROR: -0.06% RESULT: NOTE 01: ADMINISTRATION RATE ACCURACY SET ±5.0% IN ACCORDANCE WITH IEC/EN60601-2-24. NOTE 02: A 500ML GRADUATED GLASS BEAKER WAS USED, CODE TEC-252719, CERTIFICATE Nº 1428/2022. NOTE 03: DIGITAL STOPWATCH KI0057 IS USED TO MEASURE TIME, CALIBRATION VALIDITY: 06/2024. [VISUAL ANALYSIS]: EQUIPMENT APPEARS NORMAL AS USED. [CONCLUSION]: IN THE ANALYSIS OF THE HISTORY OF USE, NO EVIDENCE OF ERROR IN THE INFUSED VOLUME OR INFUSION TIME WAS FOUND. THE RESULT OF THE FUNCTIONAL TEST TO ANALYZE THE PERFORMANCE OF THE EQUIPMENT CONCLUDED THAT IT IS WORKING PRECISELY ACCORDING TO THE TECHNICAL SPECIFICATION. UNCONFIRMED TECHNICAL COMPLAINT. 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.

    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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "UNDERINFUSION" ACCORDING TO THE CUSTOMER: "IN THE 7TH STAGE, THE INFUSION PUMP WAS REPROGRAMMED WITH THE MEDICATION RITUXIMAB 350ML/H FOR INFUSION IN 30 MINUTES, ACCORDING TO MEDICAL PRESCRIPTION. ACCOMPLISHED DOUBLE CHECK WITH 2 NURSES. IT WAS OBSERVED THAT THE BEG OF MEDICINE STILL CONTAINS A VERY HIGH VOLUME FOR THE CURRENT STAGE OF MEDICATION WITH AN IRREGULAR DRIP, FILLING THE BURETTE OF THE MEDICINE. THE NURSE CHANGED THE INFUSION PUMP AND RETURNED WITH THE PRESCRIBED SCHEDULE AND ADMINISTRATION OCCURRED AS EXPECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986511 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown