BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 15526081 · Received October 1, 2022

    Report

    Report Number
    9610825-2022-00393
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Report Date
    January 12, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: G030102. 2.5 HOURS OF OPERATION: 48. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. BASED ON THE DEVICE HISTORY FILES, IT WAS DETERMINED THAT A WRONG SYRINGE WAS SELECTED. IN THE COMPLAINT DESCRIPTION THE CUSTOMER USES AN OMNIFIX 10ML SYRINGE BUT IN THE DEVICE HISTORY A BD 10ML SYRINGE WAS SELECTED. DUE TO THE INCORRECTLY SELECTED SYRINGE, A MALFUNCTION OCCURRED. 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. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGES ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. AN OPS 50ML SYRINGE AND AN OMNIFIX 10ML 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 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 +0,89%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 3.5 DISASSEMBLING: DUE TO AN APPLICATION ERROR AND THE FACT THAT THE PUMP IS IN A VERY GOOD CONDITION, IT WAS DECIDED NOT TO DISASSEMBLE IT. FURTHERMORE, THIS IS A US PUMP. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. BASED ON THE DEVICE HISTORY FILES, IT WAS DETERMINED THAT A WRONG SYRINGE WAS USED.

    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 BY BBM SALES ORGANIZATION IN SWITZERLAND: "OVERINFUSION" "PUMP INFUSED THE DRUG 3 MINUTES EARLY EVEN THOUGH THE SETTINGS WERE SET TO INFUSE OVER 12 MINUTES. THE 3 MINUTE CLOCK WARNING CAME ON AT 6 MINUTES INSTEAD OF 9 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478544 PERFUSOR SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown