BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 17807845 · Received September 25, 2023

    Report

    Report Number
    9610825-2023-00438
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 17, 2023
    Report Date
    November 15, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 (B)(4). THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. 2. RESULTS: 2.1 THE DEVICE HISTORY FILES WERE ANALYZED. THE INFUSION WAS STARTED ON (B)(6) 2023 AT 06:12 PM. ON (B)(6) 2023 AT 03:40 AM THE PRE ALARM "BATTERY NEAR EMPTY" OCCURRED. 30 MINUTES LATER THE ALARM "BATTERY EMPTY" OCCURRED AND THREE MINUTES LATER THE PUMP SWITCHED OFF BY ITSELF AND THE INFUSION STOPPED. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE AND ALARM HISTORY. 3. JUDGMENT: 3.1 THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE AND ALARM HISTORY, NO MALFUNCTION OF THE DEVICE WAS FOUND. 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 SINGAPORE: "NUH-8713030-SN(B)(6)-ALLEGED PUMPED AUTO" ACCORDING TO THE CUSTOMER: "PUMP WAS SUPPOSED TO BE RUNNING A THERAPY BUT WAS FOUND TO BE SHUT DOWN AND HAVING A VOLUME DISCREPENCY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810278 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown