BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 14402534 · Received May 13, 2022

    Report

    Report Number
    9610825-2022-00170
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    December 23, 2021
    Report Date
    August 18, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) 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: 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: N030005. 2.5 HOURS OF OPERATION: 2072. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO INFUSION ON THE DAY OF OCCURRENCE WAS STARTED. THE INFUSION WAS INVESTIGATED, AT THIS NO ABNORMALITIES WERE FOUND. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE CAN BE LOCATED. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A TERUMO 50ML 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. 3.4 INDIVIDUAL INSPECTION: 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 +1,48%. 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. ASSESSMENT: 4.1 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION" CUSTOMER INFORMATION: "PUMP WAS REPORTEDLY ADMINISTERING QUICKER THAN PROGRAMMED - NURSE REPORTED SETTING A SEPARATE INFUSION TIMER (SECONDARY DEVICE) FOR WHEN INFUSION WOULD END - THE PUMP WAS REPORTED TO FINISH 5-15 MINUTES FASTER THAN THIS WAS SET FOR. THE SAME PUMP WAS USED FOR MULTIPLE INFUSIONS AND TREATMENTS ACROSS THE WHOLE DAY WITH EACH INFUSION REPORTED TO HAVE FINISHED QUICKER THAN PROGRAMMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024219 PERFUSOR SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown