BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 18477170 · Received January 9, 2024

    Report

    Report Number
    9610825-2023-00677
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 3, 2023
    Report Date
    April 12, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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: L030003. 2.5 HOURS OF OPERATION: 7395. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2023-12-03 AT 16:00 PM WERE INVESTIGATED. A OPS 20ML SYRINGE WAS INSERTED AND WAS FILLED TO 1ML. THE INFUSION STARTED WITH A RATE OF 3ML/H AND A BOLUS OF 0,44ML WAS GIVEN. A FEW MINUTES LATER THE PRE-ALARM "SYRINGE NEAR EMPTY" OCCURRED AND THREE MINUTES LATER THE INFUSION STOPPED BECAUSE THE SYRINGE WAS EMPTY. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. 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 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. 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 +0,61%. 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. 3.6 TEST EQUIPMENT: DESCRIPTION: TYP NR.: LAB.-ID.-NR. N/A. N/A. N/A. 3.7 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: REF.: LOT: OPS 50ML SYRINGE. 8728844F. 22D28D8001. 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 400633941. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. DELIVERY RATE DEVIATION GENERAL INFORMATION: COMPLAINT: (B)(4) ---------------------------------------------------------------- INFORMATION TO THE SAMPLE: MODEL: PERFUSOR SPACE ARTICLE NUMBER: 8713030 SERIAL NUMBER/BATCH: (B)(6) SOFTWARE VERSION: L030003 HOURS OF OPERATION: 7395 FURTHER INFORMATION: N/A ---------------------------------------------------------------- INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM (B)(6) 2023 AT 16:00 PM WERE INVESTIGATED. A OPS 20ML SYRINGE WAS INSERTED AND WAS FILLED TO 1ML. THE INFUSION STARTED WITH A RATE OF 3ML/H AND A BOLUS OF 0,44ML WAS GIVEN. A FEW MINUTES LATER THE PRE-ALARM "SYRINGE NEAR EMPTY" OCCURRED AND THREE MINUTES LATER THE INFUSION STOPPED BECAUSE THE SYRINGE WAS EMPTY. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. 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. 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 +0,61%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24 THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "DELIVERY RATE DEVIATION" ACCORDING TO THE COMPLAINANT THERE IS A SUSPECTED RATE DEVIATION IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543581 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown