BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFUSOR®

    MDR report key: 23238297 · Received October 7, 2025

    Report

    Report Number
    9610825-2025-00578
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORTED 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K092313.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AN INVESTIGATION WAS CONDUCTED FOLLOWING A TECHNICAL COMPLAINT REGARDING AN INFUSION DEVICE. THE USER REPORTED AN ERROR IN THE INFUSION VOLUME (+ 1900%) AND INFUSION TIME (-5900%) ON 2025-09-08, CLAIMING THEY HAD PROGRAMMED THE DEVICE TO DELIVER 1 ML AT A FLOW RATE OF 1 ML/H. HOWEVER, A REVIEW OF THE EQUIPMENT'S USAGE HISTORY REVEALED NO RECORD OF SUCH PROGRAMMING. INSTEAD, THE SYSTEM LOGS SHOWED MULTIPLE VOLUME AND FLOW RATE SETTINGS ON THAT DATE, INCLUDING VOLUMES OF 30 ML, 20 ML, 15 ML, AND 50 ML, AND FLOW RATES OF 18 ML/H, 40 ML/H, 90 ML/H, 50 ML/H, AND 2 ML/H. THE ANALYSIS FOCUSED ON THE LAST RECORDED INFUSION ON 2025-09-08. AT 15:27:53, THE USER PROGRAMMED A VOLUME OF 50 ML, FOLLOWED BY A FLOW RATE OF 50 ML/H AT 15:27:57. THE INFUSION BEGAN AT 15:27:58. LATER, AT 15:56:14, THE USER ADJUSTED THE FLOW RATE TO 2 ML/H, AT WHICH POINT 23.59 ML HAD ALREADY BEEN INFUSED. THE INFUSION WAS STOPPED AT 16:09:40, WITH A TOTAL INFUSED VOLUME OF 24.04 ML. NO DISCREPANCIES WERE FOUND IN THE VOLUME OR TIME OF INFUSION; THE PROCESS FOLLOWED THE PROGRAMMED PARAMETERS AND USER ACTIONS PRECISELY. TO VERIFY THE EQUIPMENT'S FUNCTIONALITY, TWO TESTS WERE PERFORMED USING THE LAST RECORDED SETTINGS. THE FIRST TEST USED THE 50 ML/H FLOW RATE AND 50 ML VOLUME, RESULTING IN AN EXACT INFUSION OF 50 ML OVER 1 HOUR AND 2 SECONDS, WITH A NEGLIGIBLE ERROR OF +0.1%. THE SECOND TEST USED THE 2 ML/H FLOW RATE AND 2 ML VOLUME, WHICH ALSO SHOWED NO ERROR IN VOLUME OR TIME. BOTH TESTS WERE APPROVED, CONFIRMING THE DEVICE'S ACCURACY. THE DEFECT COULD NOT BE CONFIRMED, AND THE DEVICE WAS DEEMED TO BE FUNCTIONING CORRECTLY. THE EQUIPMENT WAS FOUND TO BE IN NORMAL USED CONDITION. BASED ON THE ANALYSIS AND TEST RESULTS, NO ERRORS WERE DETECTED IN THE INFUSED VOLUME OR INFUSION TIME. ALTHOUGH THE USER DID OPERATE THE DEVICE ON THE REPORTED DATE, THE SPECIFIC PROGRAMMING THEY DESCRIBED WAS NOT FOUND IN THE SYSTEM RECORDS. NOTE: THIS REPORTED 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

    ACCORDING TO THE EVENT DESCRIPTION: "CLONIDINE WAS ADMINISTERED VIA AN INFUSION PUMP PROGRAMMED FOR ONE HOUR. AFTER 10 MINUTES, THE NURSING TECHNICIAN NOTICED THAT 20 ML OF SOLUTION HAD ALREADY BEEN INFUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651269 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| L