BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 17913864 · Received October 11, 2023

    Report

    Report Number
    9610825-2023-00461
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Report Date
    November 22, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 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: PERFUSOR SPACE. 2.2 ARTICLE NUMBER: 8713030. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: J030006. 2.5 HOURS OF OPERATION: 3586. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE HISTORY FILES OF 2023-06-22 WAS INVESTIGATED. NO ABNORMALITIES WERE FOUND. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (31-01-034) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED PARTS ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A OMNIFIX 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. 3.4 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 +0,73%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 3.5 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. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED 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). 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 BY BBM SALES ORGANIZATION IN BELGIUM: "OVER INFUSION". ACCORDING TO THE CUSTOMER: "THE CUSTOMER COMPLAINS THAT THE DEVICE DELIVERS THE THERAPY TOO QUICKLY (SOMETIMES 4 HOURS BEFORE THE THEORETICAL END DATE OUT OF A 24-HOUR PERIOD!). I CHECKED, THE CUSTOMER IS INDEED USING OMNIFIX 10ML LL SYRINGES AND THE DEVICE WAS SERVICED ONCE IN (B)(6) 2020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628862 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030 5059427122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown