BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2900205 · Received November 20, 2012

    Report

    Report Number
    9610825-2012-00241
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 20, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). (B)(4). IN A F/U CALL TO THE FACILITY, THE REPORTER STATED THAT THE PUMP INVOLVED IN THE EVENT WAS RETURNED TO HIM WITH THE IV SET STILL LOADED IN THE PUMP. HE OBSERVED THE SET WAS TWISTED IN THE PUMP. HE TESTED THE PUMP IN ITS CURRENT STATE AS RECEIVED WITH THE SAME PARAMETERS THAT WERE USED DURING THE REPORTED INCIDENT. HE OBSERVED A FREE FLOW CONDITION; THE BAG WAS EMPTY WITHIN 8 - 10 HOURS. HE ALSO PERFORMED A MECHANICAL OCCLUSION TEST AS INSTRUCTED TO HIM BY B BRAUN TECHNICAL SUPPORT. THE SET WAS TESTED AND IT FAILED, IT DID NOT REACH THE MINIMUM SPEC OF (B)(4). THE PUMP WAS THEN TESTED WITH TWO NEW SETS WITH THE SAME PARAMETERS AND TUBING CORRECTLY LOADED AND THE PUMP OPERATED AS PROGRAMMED. THE REPORTER ALSO INDICATED THE STAFF WILL BE HAVING ADD'L TRAINING IN PROPERLY LOADING THE IV SETS INTO THE PUMP. THE ACTUAL PUMP INVOLVED IN THE INCIDENT HAS NOT BEEN RETURNED FOR EVAL. RISK MGMT AT THE REPORTING FACILITY HAS NOT MADE A DETERMINATION IF THE PUMP WILL BE RELEASED FOR EVAL. WITHOUT THE ACTUAL PUMP OR PUMP LOG, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO CONCLUSION CAN BE DRAWN. IF THE PUMP OR THE PUMP'S OPERATION LOG IS RETURNED AND/OR ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PUMP WAS PROGRAMMED TO INFUSE AT 6.49 ML/HR; 220 ML WAS IN THE BAG AND THE BAG WAS EMPTY WITHIN 12 HOURS. INCIDENT DATE: (B)(6) 2012 AT 6:30 AM. NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other