BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR ®

    MDR report key: 19668154 · Received July 3, 2024

    Report

    Report Number
    9610825-2024-00547
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: PERFUSOR SPACE ARTICLE NUMBER: 8713030 SERIAL NUMBER/BATCH: (B)(4). SOFTWARE VERSION: N030005 HOURS OF OPERATION: 7490 FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-03-10 WERE INVESTIGATED. A B.BRAUN OMNIFIX 20ML SYRINGE WAS SELECTED AND THE SYRINGE WAS FILLED TO APPROX 6ML. THE INFUSION STARTED WITH A RATE OF 54,3ML/H AND A VOLUME OF 18,1ML. AFTER 2 MINUTES THE PRE-ALARM "SYRINGE NEAR EMPTY" OCCURRED. AT THIS TIME, 2,26ML WAS INFUSED. THE INFUSION STARTED AGAIN WITH A RATE OF 24,3ML/H FOR ONE MINUTES. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (44-03-391) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED PARTS ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A BBRAUN 50 ML SYRINGE WAS INSERTED, AND THE PUMP IDENTIFIED THE SYRINGE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. INDIVIDUAL INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW 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 +0,63%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. THE TEST WAS PERFORMED WITH A OPS 50ML SYRINGE. A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW 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 +0,52%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. THE TEST WAS PERFORMED WITH A OMNIFIX 20ML SYRINGE. 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. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: INFUSED DRUGS TOO FAST- PARACETAMOL. I WAS WITH THE PATIENT AT THE TIME. THE PATIENT WAS UNDERGOING A PARACETAMOL INFUSION. I REALIZED THE SPEED OF INFUSION WAS TOO FAST AND STOPPED THE INFUSION. THE PATIENT WAS NOT HARMED AND NO PROCEDURES WERE DELAYED. NO PROCEDURES WERE BEING PERFORMED AT THE TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447620 PERFUSOR ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown