BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 20463999 · Received October 16, 2024

    Report

    Report Number
    9610825-2024-00773
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Report Date
    October 16, 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). 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. GENERAL INFORMATION: COMPLAINT: (B)(4). ---------------------------------------------------------------- INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050 SERIAL NUMBER/BATCH: (B)(6) SOFTWARE VERSION: L030003 HOURS OF OPERATION: 14243 FURTHER INFORMATION: N/A. ---------------------------------------------------------------- INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-09-10 WERE INVESTIGATED. A SPACE LINE WAS INSERTED, AND THE INFUSION STARTED WITH A RATE OF 250ML/H AND A VOLUME OF 1000ML OVER 4 HOURS. THE INFUSION WAS INTERRUPTED BY UPSTREAM ALARM, PRESSURE ALARM OR STANDBY MODE. INFUSION WAS CONTINUED. AT THE END OF THE INFUSION, THE VOLUME WAS DONE, AND THE KVO-MODE (KEEP VEIN OPEN) STARTED. THE INFUSION WAS STOPPED, AND THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE SEAL ON THE LOWER HOUSING WERE MISSING. THE DEVICE IS SLIGHTLY DIRTY AND A BENT RIBBON CABLE OF THE OPERATING UNIT WAS FOUND. 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 -3,17%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24) THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. IT COULD BE FOUND LIQUID RESIDUES ON THE EMC PROTECTION SHIELD, THE BOTTOM INNER FRAME AND THE LOWER HOUSING. ---------------------------------------------------------------- JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: A PATIENT HAD 1L IVI+KCL OVER 4 HOURS (250ML/HR). THE PUMP WAS CHECKED BY X2 NURSES TO ENSURE ALL DATE WAS PUT IN CORRECTLY. THE BRAUN PUMP BLEEPED TO ALARM THAT THE INFUSION HAD FINISHED. HOWEVER WHEN LOOKING, OVER HALF THE BAG OF FLUIDS HAD NOT BEEN ADMINISTERED. I EXPLAINED TO THE PATIENT WHAT HAD HAPPENED AND APOLOGISED THAT THIS WOULD MEAN THE FLUIDS WOULD NEED TO BE RESTARTED, MEANING A LONGER STAY IN HOSPITAL. THE FLUIDS HAVE HAD TO RECOMMENCED AS PRESCRIBED AND HAVE USED A DIFFERENT BRAUN PUMP. CLINICAL TECHNOLOGY CONTACTED AND ARE COMING TO COLLECT THE BRAUN PUMP. ANP LOOKING AFTER PATIENT ALSO AWARE OF THE INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374863 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown