BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 14488989 · Received May 24, 2022

    Report

    Report Number
    9610825-2022-00188
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Report Date
    November 29, 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 (B)(4) INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN SÃO GONÇALO, BRAZIL: THE USER DID NOT REPORT THE DATE OF THE OCCURRENCE AND DID NOT INFORM THE VOLUME OR FLOW THAT WAS IN USE; WITHOUT THIS INFORMATION THERE IS NOTHING TO SEARCH IN THE USAGE HISTORY. AS THE USER DID NOT PROVIDE THE NECESSARY INFORMATION FOR THE INVESTIGATION, FUNCTIONAL TESTS FOR ATTESTING THAT THE EQUIPMENT IS OPERATIONAL WERE PERFORMED. "THE EQUIPMENT PASSED THE FUNCTIONAL TESTS. TECHNICAL COMPLAINT OF UNCONFIRMED INFUSION ERROR".

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION". ACCORDING TO THE CUSTOMER: "CUSTOMER REPORTED THAT THE PUMP FINISHED THE INFUSING BEFORE THE PROGRAMMED TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166025 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown