BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19371446 · Received May 22, 2024

    Report

    Report Number
    9610825-2024-00405
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 22, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. UNDERINFUSION. 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE. 2.2 ARTICLE NUMBER: 8713050. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030004. 2.5 HOURS OF OPERATION: 17672. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM (B)(6) 2024 AND (B)(6) 2024 WERE INVESTIGATED. A SPACE LINE NEUTRAPUR WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 50ML/H AND A VOLUME OF 150ML ABOUT 3 HOURS. THE INFUSION WAS STOPPED FOR ONE MINUTE AND WAS CONTINUED. THE VOLUME WAS REACHED AND THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. ALSO, THE DEVICE ALARMS 2203, 2207 AND 2208 (STEPMOTOR NOT HIGH, MIDDLE, ZERO CURRENT) WAS FOUND IN THE ALARM HISTORY, SEVERAL TIMES. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (353-01-095) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE BUT A DAMAGE ON THE OPERATING UNIT WAS FOUND. 3.3 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. 3.4 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. 3.5 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 -1,07%. ((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. 3.6 DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. ADDITIONAL TO THE DAMAGE ON THE METAL FRONT SHEET FROM THE OPERATING UNIT, NO OTHER VISIBLE DAMAGE WAS FOUND. 4. JUDGMENT: 4.1 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 COMPLAINANT A PATIENT UNDERWENT A RED CELL CONCENTRATE (RCC) TRANSFUSION COMMENCED ON (B)(6) 2024 AT 10PM. TRANSFUSION COMPETED AT 1:00AM. VOLUME TO BE INFUSED (VTBI) WAS 150 MILLILITERS (ML). AT ALARM SHOWED VTBI INFUSED. REPORTEDLY IN THE MORNING THE NEXT DAY, 6-7 AFTER TRANSFUSION, THE BLOOD BAG STILL LOOKED FULL. THE BLOOD BAG HAS OVER 300 MILLILITERS (ML) BUT REQUIRED VOLUME IS ONLY 150 MILLILITERS (ML). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994029 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown