BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19319317 · Received May 15, 2024

    Report

    Report Number
    9610825-2024-00366
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    July 10, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). 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.

    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. ADDITIONAL INFORMATION: H4 DEVICE MANUFACTURER DATE. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050, SERIAL NUMBER/BATCH: (B)(6), SOFTWARE VERSION: N030004, HOURS OF OPERATION: 20258, FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE HISTORY FILES OF THE DEVICE WERE READ AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE HISTORY LOG. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE WAS SLIGHTLY DIRTY, BUT NO VISIBLE DAMAGE WAS FOUND. FUNCTIONAL INSPECTION: THE FUNCTION TEST REVEALED A DEFECTIVE KEYBOARD. THE FUNCTION TEST REVEALED A DEFECTIVE KEYBOARD. THE OK, AND DOOR OPEN, ARROW BUTTON DOES NOT WORK. DISASSEMBLING: DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. JUDGMENT: THE COMPLAINT COULD BE CONFIRMED. THE FAULTY FUNCTION COULD BE REPRODUCED. THE OPERATING UNIT IS FAULTY. ADDITION INFORMATION: WE RECOMMEND REPLACING THE OPERATING UNIT.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT THE PATIENT WAS RECEIVING CHEMOTHERAPY TREATMENT VIA INFUSION PUMP BUT WHEN SHE REACHED THE END OF THE INFUSION AND SHE WAS ABOUT TO RECEIVED THE FLUSH THE PUMP STOPPED WORKING. REPORTEDLY THE BUTTONS WERE NOT RESPONDING AND PUMP WOULD NOT OPEN. THE PATIENT WAS DISCONNECTED AND THE CHEMO LINE WAS LEFT STUCK IN THE PUMP. THE PATIENT DID NOT RECEIVED THE LAST 14 MILLILITERS (MLS) OF HER TREATMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519132 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female