BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19856857 · Received July 29, 2024

    Report

    Report Number
    9610825-2024-00609
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 29, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 (B)(6). 2.4 SOFTWARE VERSION: N030004. 2.5 HOURS OF OPERATION: 8171. 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 WERE INVESTIGATED. A SPACE LINE WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 140ML/H AND A VOLUME OF 330ML. 2 HOURS LATER THE INFUSION WAS STOPPED AND THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. 3.2 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. (PICTURES ARE ATTACHED TO THE PC NOTIFICATION) 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: 0,53 BAR (SHOULD BE: 0,1-0,7 BAR), PRESSURE STAGE 9: IS: 1,29 BAR (SHOULD BE: 0,8-1,4 BAR). THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 2,06 BAR (SHOULD BE: 1,8-2,5 BAR), PMIN: IS: 1,76 BAR (SHOULD BE: >1,5 BAR), SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,98 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 -0,56%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: (B)(4) 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 24D21E8ST1 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

    ACCORDING TO THE EVENT DESCRIPTION: REASON OF COMPLAINT: UNDERINFUSION OF BLOOD TRANSFUSION. DIRECT SPIKE INTO SOFT BAG. THERAPY: STARTED 1655 HOURS , WITH RATE 140ML/H, EXPECTING 2 HOUR FOR COMPLETION. AT 1854 HOURS, NEAR THE COMPLETION TIMING, THE PHYSICAL BAG WAS STILL OBSERVED TO BE HALF FULL, PUMP INDICATED 277.8ML WAS ALREADY INFUSION. THERAPY DISRUPTED, CONTINUED ON ANOTHER PUMP TILL COMPLETION, APPROXIMATELY REQUIRING AROUND 100 ML ADDITIONAL VTBI FOR COMPLETION. A PREVIOUS THERAPY OF TRANSFUSION WAS OBSERVED COMPLETED WITHOUT ISSUES ON INCIDENT PUMP. PATIENT CONDITION UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244877 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 96984564D9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown