BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2524706 · Received April 4, 2012

    Report

    Report Number
    9610825-2012-00036
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 3, 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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT #(B)(4). AT THIS TIME, THE REPORTING FACILITY IS UNSURE IF THEY WILL RETURN THE PUMP FOR A DETAILED INVESTIGATION. ALTHOUGH THE PUMP ASSOCIATED WITH THIS COMPLAINT HAS NOT BEEN RETURNED TO DATE, THE PUMP'S OPERATIONAL LOG WAS OBTAINED FROM THE REPORTING FACILITY AND ANALYZED. IT WAS CONFIRMED THAT THE SOFTWARE VERSION ON THIS PUMP IS (B)(4). A REVIEW OF THE OPERATION LOG INDICATED ON (B)(6) 2012 AT 10:23:51PM, A STANDARD INFUSION OF MORPHINE WITH A RATE OF 1.0ML/HR WAS PROGRAMMED USING THE DRUG LIBRARY. THE INFUSION WAS STARTED AT 10:24:05PM AND WAS MANUALLY STOPPED AT 1:52:52AM ON (B)(6) 2012 WITH A TOTAL VOLUME INFUSED OF 3.47ML OR 99.9% OF THE EXPECTED VOLUME. THE LOG ALSO SHOWS THAT AT 1:47:51AM, 5 MINS PRIOR TO THE INFUSION BEING STOPPED, THE PUMP DOOR WAS OPENED AND A "HINT;FCT. ONLY IN STOP;" MESSAGE WAS DISPLAYED. THIS MESSAGE IS DISPLAYED WHEN A KEY IS PUSHED AT A TIME WHEN THE FUNCTION CAN NOT BE EXECUTED. AT 1:52:54AM ON (B)(6) 2012, THE INFUSION WAS RESTARTED AND IMMEDIATELY STOPPED MANUALLY AT 1:52:56AM, NO DRUG WAS INFUSED. AT 1:53:01AM, THE INFUSION WAS AGAIN STARTED AND THEN MANUALLY STOPPED AT 1:53:06AM. THE INFUSION WAS RESTARTED A THIRD TIME AT 1:53:26AM AND WAS STOPPED AT 1:56:27AM WITH A TOTALED VOLUME INFUSED OF 0.06ML OR 102.9% OF THE EXPECTED VOLUME. THE PUMP WAS PLACED ON STAND-BY AND WAS TURNED OFF AT 2:01:15AM ON (B)(6) 2012. ALL THE VOLUMES INFUSED WERE WITHIN THE 100 +/- 5% SPECIFICATION. THE PUMP HAD SOFTWARE VERSION (B)(4) INSTALLED. AS INDICATED BY THE REPORTING FACILITY, THE PT DID NOT EXPIRE AS A RESULT OF THE REPORTED INCIDENT. BASED ON THE RESULTS OF THIS INVESTIGATION, AND THE REVIEW OF THE PUMP LOG, THE PUMP APPEARED TO OPERATE AS INTENDED AND NO DEFINITIVE CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR. IF THE PUMP IS RETURNED FOR EVAL AND/OR ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PRODUCT# 8713050U - INFUSOMAT SPACE PUMP, SN #(B)(4). PROBLEM: OVERINFUSION OF MORPHINE. THE PT WAS ON COMFORT CARE AND RECEIVING A PRIMARY MORPHINE DRIP AT 1ML/HR. THE 100 ML BAG WAS HUNG AT 2124. IT WAS FOUND EMPTY AT 0047. THE DRUG LIBRARY WAS UTILIZED. HOURLY ROUNDING WAS DONE AT 2200, 2300 BUT NOT 2400 DUE TO ADMITTING ANOTHER PT. WHEN CHECKED AT 0047 ,THE PUMP WAS EMPTY. REVIEW OF THE PUMP HISTORY SHOWS THE PUMP WAS RUNNING AT 1 ML/HR AND THAT ONLY 3.47 ML HAD INFUSED BUT THE ENTIRE 100 ML HAD ACTUALLY INFUSED. THE PUMP HISTORY DOES NOT REVEAL ANY USER ERROR. THE PUMP, TUBING AND BAG ARE SEQUESTERED IN THE RISK MANAGER OFFICE. THE PT'S RESPIRATIONS REMAINED IN THE 40'S. THE PT DID EXPIRE 7 HRS LATER. THE PT DID NOT EXPIRE DUE TO THE OVERINFUSION.

    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 91 YR Other