BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2861727 · Received December 4, 2012

    Report

    Report Number
    9610825-2012-00256
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 4, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM LAB IN (B)(4) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): DEVICE ALARM: "PT ON RESPIRATOR SEDATED ON ULTIVA AND PROPOFOL. INFUSION PUMP THAT GAVE PROPOFOL GIVES DEVICE ALARM AND PROPOFOL FLOWS FREELY INTO THE PT. THE PT RECEIVED AN UNINTENDED BOLUS OF PROPOFOL, BUT THE INFUSION WAS STOPPED AND SWITCHED OVER TO ANOTHER PUMP."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other