BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11170747 · Received January 14, 2021

    Report

    Report Number
    9610825-2020-00370
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 18, 2020
    Report Date
    March 30, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE INFUSOMAT SPACE 8713050 WITH SERIAL NO. (B)(6) WAS INVESTIGATED ACCORDING THE TECHNICAL SAFETY CHECK (TSC). DURING THE VISUAL INVESTIGATION NO DAMAGES COULD BE FOUND ON THE HOUSING PARTS. THE SAFETY CLAMP WITH INTEGRATED THE FREE FLOW CLAMP WORKED ACCORDING THE SPECIFICATION. A FLOW MEASUREMENT WAS PERFORMED. NO FLOW DEVIATION COULD BE DETECTED. ACCORDING THE INVESTIGATION RESULT THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(4). IF AN INVESTIGATION REPORT IS AVAILABLE, A FOLLOW-UP REPORT WILL CREATED. 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 · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4). FREE FLOW OPERATING UNIT CUSTOMER INFORMATION: IT WAS OBSERVED THAT EVEN IF THE PUMP WAS TURNED OFF, THE DRUG WAS STILL INFUSING. CLAMP OF THE EQUIPMENT ALLOWED FREE FLOW WHICH CAUSED HYPERTENSION IN THE PATIENT. THE PATIENT'S DRUG WAS DISCONNECTED AND THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70200 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1