BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 18314274 · Received December 12, 2023

    Report

    Report Number
    9610825-2023-00578
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    October 10, 2023
    Report Date
    May 2, 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). 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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: L030003. 2.5 HOURS OF OPERATION: 19979. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2023-10-10 WERE INVESTIGATED. A SPACE LINE WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 100ML/H AND A VOLUME OF 302ML. AFTER 3 HOURS THE PRE-ALARM "VTBI NEAR END" OCCURRED. THE INFUSION WAS STOPPED. AT THIS, 301,82ML WAS INFUSED. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (12/2021) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. 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 ELECTRONIC PRESSURE CUT-OFF WAS CHECKED: PRESSURE STAGE 2: IS: 0,48 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 1,30 BAR (SHOULD BE: 0,8-1,4 BAR) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 2,01 BAR (SHOULD BE: 1,8-2,5 BAR) PMIN: IS: 1,71 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,73 BAR (SHOULD BE: >1,2 BAR) 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 +2,06%. ((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: 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. 3.7 TEST EQUIPMENT: DESCRIPTION: TYP NR.: LAB.-ID.-NR. SIKA MH3151 QF04198 3.8 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: REF.: LOT: INFUSOMAT SPACE LINE 8700036SP 23K24E8ST5 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "UNDERINFUSION" ACCORDING TO THE COMPLAINANT, AN ISSUE WITH "VOLUMES DELIVERED" WAS EXPERIENCED AND THE USER WANTED TO CONFIRM THAT THE CORRECT VOLUMES WERE INPUT INTO THE PUMP. ADDITIONAL INFORMATION WAS PROVIDED WHICH REVEALED THAT THE INCIDENT OCCURRED ON OCTOBER 10, 2023. THE BLOOD TRANSFUSION COMMENCED AT 12:00 HOURS (HRS) AND WAS STOPPED AT 16:00 HRS. TRANSFUSION WAS 302 MILLILITERS (ML) TO BE INFUSED OVER 4 HOURS, SO THE INFUSION PUMP SHOULD HAVE BEEN SET TO INFUSE AT 75.5MLS PER HOUR X 4 HOURS. AFTER FOUR (4) HOURS, APPROXIMATELY 100MLS OF THE TRANSFUSION HAD BEEN INFUSED, RESULTING IN 200MLS OF BLOOD BEING DISCARDED AFTER FOUR (4) HOURS AS PER HOSPITAL PROTOCOL. THIS INCIDENT OCCURRED ON WARD 2. AN AGENCY NURSE AND ONE MEMBER OF STAFF RGN CHECKED THE BLOOD AT START OF INFUSION. NO HARM TO PATIENT, HOWEVER, THE PATIENT DID NOT RECEIVE THE FULL AMOUNT OF THE INTENDED BLOOD. THE AGENCY NURSE "FELT IT WAS AN ISSUE WITH THE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082360 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown