BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17291493 · Received July 10, 2023

    Report

    Report Number
    9610825-2023-00336
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Report Date
    October 19, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT 400606619. THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: 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)(4). 2.4 SOFTWARE VERSION: N030004. 2.5 HOURS OF OPERATION: 12045 HOURS. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO DATE OF THE INCIDENT WAS GIVEN FROM THE COSTUMER. THEREFORE, THE LAST HISTORY FILES FROM 2023-06-09 TO 2023-06-12 WERE INVESTIGATED. INSIDE THE HISTORY FILES SEVERAL UPSTREAM AND PRESSURE ALARMS COULD BE DETECTED (REASON FOR THAT ALARMS COULD NOT BE CLARIFIED). FURTHERMORE, NO ANOMALIES COULD BE DETECTED. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS WERE INTACT AND UNDAMAGED. NO SEAL WAS AVAILABLE. THE DEVICE IS IN A CLEAN STATE. THE HOUSING UPPER- AND LOWER PART SHOWS SCRATCHED BETWEEN THE SPACES. FURTHERMORE, NO ANOMALIES COULD BE DETECTED. 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 DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS FOR THE ELECTRONIC PRESSURE CUT OFF. THE MECHANICAL PRESSURE CUT OF VALUES ARE OUT OF TOLERANCE. THE REASON FOR THAT COULD NOT BE CLARIFIED. 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 +3,50%. ((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. 3.6 INDIVIDUAL INSPECTION: IN THE DEVICE HISTORY FILES SEVERAL UPSTREAM ALARMS COULD BE DETECTED. A POSSIBLE REASON FOR THE DESCRIBED VACUUM BY THE CUSTOMER COULD BE THE CONFIRMED UPSTREAM ALARMS. WHEN THE ROLLER CLAMP IS CLOSED, AND THE PUMP ALARMS SEVERAL TIMES WITH AN UPSTREAM ALARM CORRECTLY AND THE CUSTOMER CONFIRMS THE UPSTREAM ALARMS BUT STILL LET THE ROLLER CLAMP CLOSED A VACUUM INSIDE THE SILICON PART COULD BE PRODUCED. THAT COULD BE REPRODUCED. 3.7 DISASSEMBLING: DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED. TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER- AND HOUSING LOWER PART WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. 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 NEITHER BE REPRODUCED NOR DETECTED IN THE HISTORY FILES. 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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION IN GERMANY: "UNDERINFUSION". ACCORDING TO THE CUSTOMER: "THE DELIVERY RATE OF THE DEVICE IS TOO LOW, SINCE A VACUUM IS CREATED AFTER EACH REVOLUTION OF THE WELL AND INFUSION LIQUID (OR AIR) IS THUS SUCKED BACK INTO THE TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806781 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown