BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19842554 · Received July 26, 2024

    Report

    Report Number
    9610825-2024-00586
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Report Date
    September 13, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    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 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: D9 DEVICE RETURNED TO MANUFACTURER. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE. ARTICLE NUMBER: 8713050. SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: N030005. HOURS OF OPERATION: 1447. PRODUCTION DATE: 2023-09-05. FURTHER INFORMATION: (B)(4). INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE'S HISTORY FILES WERE REVIEWED AND ANALYZED. DATA REVEALED NO ALARMS. A COPY OF THE SERVICE HISTORY IS INCLUDED IN THIS REPORT. VISUAL INSPECTION: A THOROUGH VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED. THE SCREW PILLAR CAPS AND LOWER HOUSING SEAL WERE INTACT AND UNDAMAGED. THE DEVICE WAS COMPLETE, CLEAN, AND FREE OF VISIBLE DEFECTS. THE ORIGINAL PACKAGING WAS UNDAMAGED, AND THE DEVICE APPEARED TO HAVE A FACTORY SEAL. PHOTOGRAPHS DOCUMENTING THE VISUAL INSPECTION ARE INCLUDED IN THIS REPORT. FUNCTIONAL INSPECTION: THE DEVICE POWERED ON AND SUCCESSFULLY COMPLETED ITS SELF-TEST. THE INFUSION LINE WAS PROPERLY INSTALLED, AND INFUSION COULD BE STARTED. THE PROBLEM OCCURS DURING TECHNICAL SAFETY CHECK. INFUSION TIME AND SUPPLY OF FLUID ARE INCORRECT, THE DEVIATION IS TOO HIGH (ABOUT 6%). THE SUPPLY CALIBRATION WAS PERFORMED. AFTER CALIBRATION, SENSORS VALUES AND SUPPLY WERE WITHIN LIMITS. INDIVIDUAL INSPECTION: N/A. DISASSEMBLING: THE DEVICE WAS OPENED, REVEALING NO VISIBLE DAMAGE OR CONTAMINATION WITHIN THE DEVICE. NO FURTHER FAULTS WERE DETECTED. JUDGMENT: THE COMPLAINT IS CONFIRMED. CALIBRATION PERFORMED. ADDITIONAL INFORMATION: N/A.

    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

    ACCORDING TO THE EVENT DESCRIPTION: THE PUMP DOES NOT DELIVER THE SET AMOUNT OF DRUG. ADDITIONAL INFORMATION FROM CUSTOMER FROM 28.06.2024: THE PUMP GAVE THE RIGHT AMOUNT OF DRUG TOO QUICKLY, THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458749 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown