BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 20993005 · Received December 20, 2024

    Report

    Report Number
    9610825-2024-00987
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Report Date
    December 20, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    ACCORDING TO THE EVENT DESCRIPTION: AT 09.00 ON (B)(6) 2024, THE SPEED WAS SET TO 500 MILLILITERS AN HOUR (ML/H) (NO SELECTED LKM), VSSI 2000 MILLILITERS (ML) IN 4 HOURS WITH 2 PIECES 1000 MILLILITER (ML) BAGS. AFTER 60 MINUTES IT WAS OBSERVED THAT IT HAS BEEN INTRODUCED A LITTLE AMOUNT. ACCORDING TO THE NURSE, THE PUMP SOUNDED A LITTLE DIFFERENT. SHE WEIGHS THE DRIP BAG AND COMPARES WITH UNUSED AND WEIGHS ONLY 200 GRAMS LESS. IT IS ESTIMATED THAT IT WENT IN ONLY 250 MILLILITERS IN 85 MINUTES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311454 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown