BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17694931 · Received September 6, 2023

    Report

    Report Number
    9610825-2023-00415
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Report Date
    September 6, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 1. GENERAL INFORMATION: COMPLAINT: (B)(4). EXAMINATION CARRIED OUT BY: (B)(6). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE 2.2 ARTICLE NUMBER: (B)(4). 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030005 2.5 HOURS OF OPERATION: 6754. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE DEVICE AND ALARM HISTORY. (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 TECHNICIAN SEAL (49-02-995) 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: 0,62 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 1,33 BAR (SHOULD BE: 0,8-1,4 BAR) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 2,03 BAR (SHOULD BE: 1,8-2,5 BAR) PMIN: IS: 1,68 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,86 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 -1,50%. ((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: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE COULD BE FOUND LIQUID RESIDUES ON THE LOWER HOUSING AND THE BOTTOM INNER FRAME. NO OTHER DAMAGES WERE FOUND. (PICTURES ARE ATTACHED TO THE PC NOTIFICATION). 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) 23D18E8ST5 ---------------------------------------------------------------- 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 GERMANY: "UNDERINFUSION". ACCORDING TO THE CUSTOMER: "ERROR: INFUSED VOLUME DOES NOT MATCH THE QUANTITY ATTACHED AS SOLUTION, TOTAL 1520 ML; BOTTLE CONTENT 1000 ML. USERS HAVE NOTICED THAT THE DROPS FALL MORE SLOWLY THAN USUAL, SOLUTION WAS STILL PRESENT IN THE CONTAINER AFTER THE SCHEDULED END OF THE INFUSION. IT WAS NOTEWORTHY THAT THE INTERMEDIATE PIECE OF THE INFUSION LINE LOOSELY CLAMPED TO THE ROLLER PUMP. ACCORDING TO USERS, THIS IS NOW MORE COMMON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639109 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown