BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5845374 · Received August 3, 2016

    Report

    Report Number
    9610825-2016-00539
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Report Date
    July 18, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER) AND B. BRAUN MEDICAL INC. (THE IMPORTER) THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN INTERNAL REPORT NUMBER (B)(4). THE DEVICE WAS RETURNED TO OUR CONTRACTED SERVICE PROVIDER FOR EVALUATION. THE AIR IN LINE SENSOR TEST WAS PERFORMED WITH THREE DIFFERENT TUBINGS, ALL THREE TESTS WERE WITHIN THE SPECIFIED RANGE. THE PUMP WAS THEN TESTED FOR 25 HOURS WITH A SET RATE OF 10ML/HR VTBI 250ML. DURING THIS TSTE THE PUMP DID NOT ALARM FOR AIR IN LINE, AND AS A RESULT, THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALTHOUGH THE REPORTED ISSUE WAS NOT CONFIRMED, DURING THE EVALUATION IT WAS DISCOVERED THAT THE WIRELESS BATTERY WAS NOT CONNECTING, SO THE BATTERY WAS REPLACED. THE DEVICE PASSED ALL TECHNICAL SAFETY CHECKS AFTER COMPLETION OF THE SERVICE ACTIVITY.. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT: OVER INFUSION. PER THE EVENT DESCRIPTION, AS REPORTED; THE PUMP ALARMED FOR AIR, THE NURSE REMOVED AIR THE PROCEEDED TO RESTART THE DRIP. THE PUMP GAVE A BOLUS INSTEAD. THIS WAS A BAG INFUSION OF LEVOPHED. THE BLOOD PRESSURE INCREASED TO 140/80 - HEART RATE DECREASED TO 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495368 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1