BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 14052460 · Received April 8, 2022

    Report

    Report Number
    9610825-2022-00121
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Report Date
    July 6, 2022
    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 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: 2. RESULTS: 2.1 A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS AND THE TECHNICAL SEAL (49-05-081) WERE INTACT AND UNDAMAGED. THE P2 CONNECTOR SHOWS OXIDIZED CONTACTS. NO VISIBLE DAMAGE IS LOCATED. 2.2 A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. AN OPS SYRINGE WAS INSERTED, THE PUMP IDENTIFIED THE SYRINGE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 2.3 THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. BECAUSE NO DATE OF THE COMPLAINT ERROR WAS STATED, THE HISTORY FILES FROM (B)(6) 2022 WAS INVESTIGATED. THE HISTORY FILES DO NOT SHOW ANY ANOMALIES. 2.4 A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FEED RATE OF 5 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF 0.21%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 2.5 DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE HOUSING UPPER WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. 3. JUDGMENT: 3.1 THE COMPLAINT COULD NOT BE CONFIRMED. A FLOWRATE DEVIATION COULD NOT BE DETECTED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. AN EXCHANGE OF THE P2 CONNECTOR IS RECOMMENDED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION". "THE SYRINGE SHOULD HAVE BEEN EMPTY, BUT THE PERFUSOR STILL INDICATED A REMAINING TIME OF 3.3 HOURS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150062 PERFUSOR SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown