BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 14303570 · Received May 6, 2022

    Report

    Report Number
    9610825-2022-00150
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 5, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: A VANCOMYCIN 260ML BAG RAN OVER 28 MINUTES AND EMPTIED THE BAG THIS MORNING. PATIENT HAD A ADVERSE DRUG REACTION. PATIENT INJURY - PATIENT DEVELOPED "RED MAN SYNDROME" FROM VANCOMYCIN INFUSING TOO QUICKLY AND REQUIRED ADMINISTRATION OF DIPHENHYDRAMINE 50MG IV X 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281590 INFUSOMAT® PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG 8713052U 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown