BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 15447144 · Received September 19, 2022

    Report

    Report Number
    9610825-2022-00374
    Event Type
    Death
    Date Received
    September 19, 2022
    Report Date
    November 9, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE PRODUCT INVOLVED IN THE REPORTED INCIDENT WAS RETURNED TO ONE OF OUR B. BRAUN FACILITIES AND THE DEVICE WAS EVALUATED BY A QUALIFIED TECHNICIAN DURING THE INVESTIGATION. WHEN THE PUMP WAS EVALUATED, THE REPORTED ISSUE WAS NOT OBSERVED. OCCLUSION PRESSURE THRESHOLD CHECKS TESTED IN SPEC. LOG REVIEW CONFIRMS PRESSURE ALARM ON 8/30/2022. LOG REVIEW SHOWS NO PRESSURE ALARM ON LAST DATE OF INFUSIONS (B)(6) 2022. PREVENTATIVE MAINTENANCE SERVICE WAS PERFORMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: "DOWNSTREAM OCCLUSION, PATIENT EXPIRED WHILE ON PUMP IN ICU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250132 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death