BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2389854 · Received December 16, 2011

    Report

    Report Number
    9610825-2011-00189
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 15, 2011
    Report Date
    December 16, 2011
    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. BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT# (B)(4). BASED ON THE SERIAL NUMBER PROVIDED BY THE USER FACILITY, B. BRAUN HAS IDENTIFIED THE SOFTWARE VERSION ON THIS PUMP IS G03. MULTIPLE FOLLOW UPS HAVE BEEN MADE WITH THE FACILITY TO OBTAIN THE PUMP FOR INVESTIGATION, BUT HAVE BEEN UNSUCCESSFUL. ON 12/15/2011, B. BRAUN WAS INFORMED THAT THE PUMP WILL NOT BE RETURNED FOR INVESTIGATION. WITHOUT THE INVOLVED DEVICE, A FULL INVESTIGATION CANNOT BE CONDUCTED. A FOLLOW UP REPORT WILL BE FILED IF THE PUMP IS RETURNED OR IF ADD'L PERTINENT INFO BECOMES AVAILABLE BASED ON THE ONGOING INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: RN WENT INTO THE PT'S ROOM TO START ANTIBIOTICS AND FOUND MULTIPLE AIR BUBBLES IN THE PRIMARY TUBING THAT THE PUMP WAS LETTING PASS THROUGH WITHOUT THE ALARM GOING OFF. TURNED OFF THE PUMP, SWITCHED TUBING AND LET (B)(4) KNOW. NO PT INJURY. THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED BY THE REPORTING FACILITIES BIOMED DEPARTMENT. DURING A FOLLOW UP CALL FROM THE FACILITIES BIOMED DEPT, IT WAS REPORTED THAT THE IV TUBING HAS LARGE BUBBLES DOWNSTREAM FROM THE PUMP. ALTHOUGH, THERE WAS CONFLICTING INFO REGARDING THE EVENT FROM THE FACILITIES STAFF. DURING BIOMED TESTING, THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED AND THE PUMP ALWAYS PROVIDED AN AIR IN LINE ALARM. IN ADDITION, THE BIOMED DEPT'S REVIEW OF THE PUMP LOG REVEALED NUMEROUS AIR IN LINE ALARMS HAD OCCURRED DURING PUMP OPERATION. AT THIS TIME THEY ARE UNSURE IF OR WHEN THEY WILL BE RELEASING THE PUMP FOR MFR'S EVAL.

    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 57 YR Other