BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 17913146 · Received October 11, 2023

    Report

    Report Number
    9610825-2023-00458
    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
    UK
    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 400619095. THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: 1. GENERAL INFORMATION: COMPLAINT: 400619095 ---------------------------------------------------------------- 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: PERFUSOR SPACE 2.2 ARTICLE NUMBER: 8713030 2.3 SERIAL NUMBER/BATCH: 570864 2.4 SOFTWARE VERSION: N030005 2.5 HOURS OF OPERATION: 1821 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 (B)(6) 2023 AND (B)(6) 2023 WAS INVESTIGATED. DURING THIS INFUSION, 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 DAMAGED PARTS ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A BD PLASTIPAK 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. THE PCA-TASTER CONNECTOR WAS CONNECTED TO THE PUMP. A PCA-THERAPY WAS SELECTED, AND THE INFUSION WAS STARTED. THE PCA-CONNECTOR WAS PRESSED, AND THE INFUSION STARTED. DURING THIS INFUSION, NO ABNORMALITIES WERE FOUND. 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 +0,57%. 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 THE UNITED KINGDOM: "DELIVERING LESS THAN REQUESTED" ACCORDING TO THE CUSTOMER: A PEDIATRIC PCA PUMP WAS RETURNED TO CLINICAL ENGINEERING FOR REPAIR WITH A NOT CARD. THE FAULT WRITTEN ON THE CARD ATTACHED TO THE PUMP STATES "PUMP DELIVERING .35 OF A ML LESS THAN REQUESTED BY THE TYPED IN PRESCRIPTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180473 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown