BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 18330594 · Received December 14, 2023

    Report

    Report Number
    9610825-2023-00585
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 12, 2023
    Report Date
    March 13, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030005. 2.5 HOURS OF OPERATION: 15320. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2023-11-12 WAS INVESTIGATED. A SPACE LINE WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 15ML/H. DURING THE INFUSION, THE "NO DROPS", "FLOW-ALARM", "TOO FEW DROPS" AND "TOO MANY DROPS" COULD BE FOUND ONE TIMES IN EACH CASE. THE REASON FOR THE ALARM COULD NOT BE CLARIFIED. NO OTHER ABNORMALITIES WERE FOUND. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS WERE INTACT AND UNDAMAGED. THE SEAL ON THE LOWER HOUSING WERE MISSING. 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. THE DROP SENSOR WAS CHECKED ACCORDING TO THE TECHNICAL SAFETY CHECK. THE DROP SENSOR OCCURRED THE FLOW ALARM AND THE NO DROPS ALARM. NO MALFUNCTION COULD BE DETECTED. 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: 0,47 BAR (SHOULD BE: 0,1-0,7 BAR). PRESSURE STAGE 9: IS: 1,16 BAR (SHOULD BE: 0,8-1,4 BAR). THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 1,83 BAR (SHOULD BE: 1,8-2,5 BAR). PMIN: IS: 1,54 BAR (SHOULD BE: >1,5 BAR). SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,69 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 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 +2,90%. ((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.

    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. 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: (B)(4). 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) 2023 WAS INVESTIGATED. A SPACE LINE WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 15ML/H. DURING THE INFUSION, THE "NO DROPS", "FLOW-ALARM", "TOO FEW DROPS" AND "TOO MANY DROPS" COULD BE FOUND ONE TIMES IN EACH CASE. THE REASON FOR THE ALARM 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 WERE INTACT AND UNDAMAGED. THE SEAL ON THE LOWER HOUSING WERE MISSING. 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. THE DROP SENSOR WAS CHECKED ACCORDING TO THE TECHNICAL SAFETY CHECK. THE DROP SENSOR OCCURRED THE FLOW ALARM AND THE NO DROPS ALARM. NO MALFUNCTION COULD BE DETECTED. 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:(B)(4) PRESSURE STAGE 9: IS: (B)(4) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS:(B)(4) PMIN: IS: (B)(4)) SAFETY CLAMP WAS CHECKED: PMIN: IS: (B)(4) 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 (B)(4). ((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. (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) 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. ADDITION INFORMATION: N/A.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FINLAND: "OVERINFUSION". ACCORDING TO THE CUSTOMER: "THE PATIENT WAS TRANSPORTED FROM THE RECOVERY ROOM WITH A DROP COUNTER, WHERE SHE OR HE WAS INFUSED WITH NORADRENALINE. THE DEVICE WORKED NORMALLY AT FIRST, BUT THEN IT STARTED TO ALARM "TOO LITTLE DROPS". THE ALARM WAS ACKNOWLEDGED AND THE DEVICE STOPPED WHEN IT WAS FOUND THAT THE LIQUID COULD FREELY DRIP INTO THE PATIENT, EVEN THOUGH IT SHOULD BE STOPPED." "THE PATIENT'S SYSTOLIC BLOOD PRESSURE ROSE QUICKLY FROM 100 -> 180 AND THE PATIENT EXPERIENCED SEVERE PAIN FROM THE SITUATION. AFTER STOPPING THE INFUSION, THE BLOOD PRESSURE DECREASED AND THE PATIENT'S CONDITION IMPROVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302423 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown