BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 22140160 · Received June 4, 2025

    Report

    Report Number
    9610825-2025-00348
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 (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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER PREMARKET SUBMISSION # GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050 SERIAL NUMBER/BATCH: (B)(6) SOFTWARE VERSION: 686N030004 HOURS OF OPERATION: 14457 FURTHER INFORMATION: N/A 3. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. DUE TO THE LACK OF A PRECISE ERROR DESCRIPTION, THE HISTORY COULD NOT BE ANALYZED EXTENSIVELY. THE LAST INFUSIONS WERE INVESTIGATED. NO ANOMALIES COULD BE DETECTED. 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 HAS SIGNS OF USE COMMENSURATE WITH ITS AGE. NO VISIBLE DAMAGE ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. PRESSURE INSPECTION: IN CHECKING THE DOWNSTREAM-SENSOR THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED, ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,92%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: (B)(4) ACCORDING TO IEC/EN 60601-2-24) ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 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 NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. ADDITION INFORMATION: THE CABLE FROM THE POWER SUPPLY IS MECHANICALLY DAMAGED AT THE P2 CONNECTOR.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "OVER INFUSION, TOO FAST DELIVERY OF THE CYTOSTATIC MEDICINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709481 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown