BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17873341 · Received October 4, 2023

    Report

    Report Number
    9610825-2023-00456
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 2, 2023
    Report Date
    October 4, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. OVERINFUSION 1. GENERAL INFORMATION: COMPLAINT:(B)(4). EXAMINATION CARRIED OUT BY: P.THEIS ---------------------------------------------------------------- 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: N030005 2.5 HOURS OF OPERATION: 5626 2.6 FURTHER INFORMATION: N/A ---------------------------------------------------------------- 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE INFUSION ON (B)(6) 2023 WAS INVESTIGATED. A SPACE LINE NEUTRAPUR WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 105,8 ML/H AND A VOLUME OF 1270ML ABOUT 12 HOURS. DURING THE INFUSION THE PRESSURE ALARM OCCURRED TWO TIMES AND THE UPSTREAM ALARM, ONE TIMES. AFTER THE UPSTREAM ALARM, THE INFUSION DOES NOT START AGAIN. AT THIS TIME, 789,23ML WAS INFUSED. THE REASON FOR THE ALARMS COULD NOT BE CLARIFIED. NO OTHER ABNORMALITIES WERE FOUND. (HISTORY FILES ARE ATTACHED TO THE PC NOTIFICATION) 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: 0,44 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 1,12 BAR (SHOULD BE: 0,8-1,4 BAR) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 1,93 BAR (SHOULD BE: 1,8-2,5 BAR) PMIN: IS: 1,62 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,91 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 +1,60%. ((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. (SEE LAB RESULTS ATTACHED TO THE PC-NOTIFICATION) 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 (B)(4). 23G19E8ST5 ---------------------------------------------------------------- 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. ADDITION INFORMATION: N/A.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN: "OVER INFUSION" ACCORDING TO THE CUSTOMER: "I HAVE RECEIVED A PUMP THAT THE DEPARTMENT CONSIDERS TO HAVE GIVEN THE WRONG VOLUME. THEY HAVE SET THE PUMP TO 1270 ML IN 12 HOURS BUT AFTER 8 HOURS THE BAG (1270 ML) WAS EMPTY. I HAVE CHECKED THE LOG AND IT SHOWS THAT THEY SET THE PUMP CORRECTLY. I HAVE DONE SEVERAL FLOW TESTS WHICH ARE OK. THE PUMP IS STILL UNDER WARRANTY. TRENDLOG WILL BE SENT WITH THE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413999 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown