BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17646206 · Received August 29, 2023

    Report

    Report Number
    9610825-2023-00401
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Report Date
    August 29, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER 400613051. 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: (B)(6). 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: N030004. 2.5 HOURS OF OPERATION: 15907 H. 2.6 FURTHER INFORMATION: 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: NO CONNECTION VIA CAN TO THE PROGRAM HIBASED WAS POSSIBLE. THE BLUE LED WAS BLINKING. A CONNECTION VIA COM WAS POSSIBLE. THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO DATE OF THE INCIDENT WAS GIVEN FROM THE COSTUMER. THEREFORE, THE LAST HISTORY FILES WERE INVESTIGATED. NO ANOMALIES COULD BE DETECTED INSIDE THE HISTORY FILES. (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 P2-CONNECTOR SHOWS OXIDIZED CONTACTS. IN ADDITION, THE RIBBON CABLE (MAINBOARD-OPERATING UNIT) SHOWS LIQUID RESIDUES. FURTHERMORE, 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: 0,36 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 0,94 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: 1,61 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,78 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 +0,55%. ((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, THE DEVICE WAS DISASSEMBLED COMPLETE. LIQUID RESIDUES COULD BE DETECTED BETWEEN THE LOWER HOUSING PART AND THE BOTTOM INNER FRAME. FURTHERMORE, NO DAMAGE OR SOILING COULD BE FOUND. (PICTURES ARE ATTACHED TO PC-NOTIFICATION) 3.7 TEST EQUIPMENT: DESCRIPTION: TYP NR.: LAB.-ID.-NR. 3.8 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: REF.: LOT: BBRAUN SPACE LINE 8700036SP 23D18E8ST5 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. THE COMPLAINT MALFUNCTION COULD NOT BE REPRODUCED ORE DETECTED INSIDE THE HISTORY FILES.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "PROBLEM OF FLOW ACCORDING TO THE NURSES. THE FLOW IS TOO FAST. THE CONNECTION WITH THE COMPUTER IS NOT POSSIBLE BECAUSE THERE IS NO CONNECTION WITH HIBASED. IT FLASHES BLUE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058602 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown