BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 14958243 · Received July 8, 2022

    Report

    Report Number
    9610825-2022-00253
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 8, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    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 MELSUNGEN AG 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 INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "OVER INFUSION/ OPERATING UNIT." CUSTOMER: "THE NPP STARTED ON (B)(6) 2022 AT 23:26 PM. IT SHOULD BE INFUSED IN 24 HOURS. ON (B)(6) 2022 I OBSERVED THAT THE INFUSION ENDED AT 20:00 PM, 3 HOURS BEFORE. I CHECKED THE INFUSION PUMP PROGRAMMING WITH DOUBLE CHECK, AND IT WAS PROGRAMMED TO INFUSE 1691ML IN 24H (70.46ML/H) ACCORDING TO MEDICAL PRESCRIPTION. THE BAG WASN´T SIGNS OF DAMAGE OR LEAKS. THE PATIENT AND COMPANION REPORTED THAT THE PUMP WASN´T OPENED OR MANIPULATED DURING THE DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908281 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown