BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19514512 · Received June 11, 2024

    Report

    Report Number
    9610825-2024-00481
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 1, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 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: N030006. HOURS OF OPERATION: 4967. FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-05-04 WITH THE DRUG SHORT NAME "TPN" WAS INVESTIGATED. A SAFESET NEUTRAPUR WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 35ML/H AND A VOLUME OF 600ML. AFTER START THE INFUSION, THE PRESSURE ALARM OCCURRED, FOUR TIMES. THE REASON FOR THE PRESSURE ALARM COULD NOT BE CLARIFIED. THE INFUSION WAS CONTINUED AND 6 HOURS AND 20 MINUTES LATER THE INFUSION WAS STOPPED. AT THIS TIME, 221,95ML WAS INFUSED. NO OTHER ABNORMALITIES WERE FOUND. 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 IS IN A CLEAN STATE AND 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 -0,66%. ((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. INSIDE THE DEVICE WAS SLIGHTLY DIRTY BUT NO VISIBLE DAMAGE WAS FOUND. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "PATIENT ON TPN CONTINUES FOR 24H AND LIPIDS FOR 20 H, WHEN I RECEIVED THE PATIENT ON THE MORNING TPN RATE WAS 35ML/HR AND TOTAL VOLUME 840 ML IN THE BAG. THE TPN BAG SHOULD BE FINISHED AT 2100H, WHEN THE RESOURCE NURSE DID HER ROUNDS SHE FOUND OUT THAT THE BAG IS EMPTY AND THE MACHINE IS BEEPING. SHE IMMEDIATELY INFORM THE CHARGE NURSE AND ME. ON CALL PHYSICIAN INFORM AS WELL AS THE TPN PHARMACIST. D10 WATER AT 35ML/H WERE HANG UNTIL THE NEXT BAG OF TPN WILL BE HANG. PATIENT SUGAR LEVEL CHECKED AND IT IS NORMAL." NOTE: MEDICATION BAG WAS A 100 ML OVER FILLED (TOTAL VOLUME IN BAG 940 ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054291 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown