BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2237226 · Received September 2, 2011

    Report

    Report Number
    9610825-2011-00116
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 28, 2011
    Report Date
    September 2, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    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 MANUFACTURER), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). B. BRAUN MEDICAL INC. FORMED A CROSS-FUNCTIONAL WORKING GROUP WITH MEMBERS FROM QUALITY, ENGINEERING, SERVICE, SALES, CLINICAL AND TECHNICAL SUPPORT AND PRODUCT MANAGEMENT WITH THE PURPOSE TO INVESTIGATE AND BRING RESOLUTION TO THE EVENTS REPORTED TO B. BRAUN FROM (B)(6) HOSPITAL. B. BRAUN TOOK A THREE-PRONGED APPROACH TO THIS INVESTIGATION: CLINICAL ON-SITE ASSESSMENT, BIOMEDICAL ON-SITE ASSESSMENT - INCLUDED PREVENTATIVE MAINTENANCE AND REPAIRS AS NEEDED ON ALL PUMPS, CUSTOMER COMPLAINT INVESTIGATION. THE CLINICAL ON-SITE ASSESSMENT WAS CONDUCTED FROM (B)(4) 2011 BY B. BRAUN CLINICAL PERSONNEL. DURING THIS ASSESSMENT, ALL HOSPITAL SHIFTS WERE COVERED AND A TOTAL OF 118 CLINICIANS WERE INCLUDED FROM 14 DIFFERENT AREAS OF CARE. THIS ASSESSMENT REVEALED NO USER RELATED ISSUES THAT COULD HAVE LED TO THIS EVENT. THE PURPOSE OF THE BIOMEDICAL ON-SITE ASSESSMENT WAS TO PHYSICALLY INSPECT ALL PUMPS WITHIN (B)(6) HOSPITAL, REPAIR AS NEEDED AND CONDUCT PREVENTIVE MAINTENANCE ACTIVITIES AS DEFINED BY THE B. BRAUN INFUSOMAT SERVICE MANUAL. OVER THE COURSE OF 8.5 DAYS FROM (B)(4) 2011, B. BRAUN TECHNICAL SERVICE TECHNICIANS PERFORMED PREVENTIVE MAINTENANCE ON 578 PUMPS. WHILE 25 PUMPS (4%) WERE REPAIRED BASED ON THE FINDINGS OF THIS ASSESSMENT, IT HAS BEEN CONCLUDED THAT THE REASON FOR THESE REPAIRS COULD NOT HAVE CONTRIBUTED TO THIS EVENT OR ANY SIMILAR EVENTS. CUSTOMER COMPLAINT INVESTIGATION RESULTS: THE ACTUAL PUMP IN THE REPORTED INCIDENT HAS NOT YET BEEN RETURNED FOR EVALUATION. HOWEVER, THE REPORTING HOSPITAL DOES ACKNOWLEDGE THIS ISSUE WAS ATTRIBUTED TO USER ERROR. THIS CONCLUSION IS SUPPORTED BY B. BRAUN'S REVIEW OF THE PUMP LOG. THE PUMP LOG REVIEW DETERMINED THAT ON (B)(6) 2011 AT 1:33 AN AMIODARONE INFUSION WAS PROGRAMMED. ALTHOUGH THE EVENT DESCRIPTION INDICATES THE PUMP WAS SET TO INFUSE AT 1MCG/MIN (33GTTS/HR), THE PUMP LOG INDICATES THE RATE WAS SET AT 33MG/MINUTE OR 1100ML/HR. THIS INFUSION RAN AT THE HIGHER RATE FOR 11 MINUTES AND 203.72 ML WAS INFUSED. THIS VOLUME IS 101% OF THE PROGRAMMED VOLUME, WHICH IS WITHIN THE SPECIFICATION OF 100% + OR - 5%. AT 2:02 ON (B)(6) 2011, THE INFUSION RATE WAS CHANGED TO THE INTENDED 1.0MG/MINUTE OR 33.33ML/HR. IN ADDITION TO THE TESTING THAT WAS CONDUCTED ON THE RETURNED PUMP, VARIOUS LOT NUMBERS OF INFUSOMAT SPACE PUMP IV TUBING SETS (B. BRAUN MATERIAL NUMBER 490036) THAT WERE DISTRIBUTED TO (B)(6) HOSPITAL WERE ALSO EVALUATED TO ELIMINATE THE SETS AS A POTENTIAL CONTRIBUTING FACTOR. THERE WERE NO VISUAL ANOMALIES IDENTIFIED AND ALL DIMENSIONS ANALYZED WERE WITHIN THE ESTABLISHED SPECIFICATIONS, INCLUDING THE SPACE TUBING SEGMENT OF THE SETS. THE TUBING SETS WERE ALSO TESTED ON A VARIETY OF INFUSOMAT SPACE PUMPS AT VARIOUS INFUSION RATES AND EACH OF THE SETS FUNCTIONED AS INTENDED. BASED ON THE INVESTIGATION, IT APPEARS THE PUMP FUNCTIONED AS PROGRAMMED AND THE EVENT WAS RELATED TO INCORRECT PROGRAMMING/USER ERROR. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE FROM THE MANUFACTURER, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THE PATIENT WAS A FRESH POST CARDIOVASCULAR SURGERY AND HAD AMIODARONE DRIP STARTED AT 1:30PM PER CSICU AMIODARONE PROTOCOL. THE NURSE PROGRAMMED THE B. BRAUN PUMP TO INFUSE 1MCG/MIN OF AMIODARONE = 33 GTTS/HOUR FOR 6 HOURS WHICH WOULD EQUAL 198 ML OF A 250 ML BAG OVER 6 HOURS. THE BEDSIDE RN NOTICED AFTER APPROXIMATELY ONE HOUR (2:30 PM) THAT THE MAJORITY OF THE 250 ML BAG (APPROXIMATELY 220 ML) HAD INFUSED OVER APPROXIMATELY 60 MINUTES. THE DRIP WAS DISCONNECTED FROM THE PATIENT. THE PATIENT DID NOT DEMONSTRATE ANY ILL EFFECT OF THE RAPID INFUSION. THE HEART RATE REMAINED STABLE IN THE 80'S AND EPICARDIAL PACING WIRES WERE IN PLACE SHOULD THE PATIENT BLOCK DOWN AFTER THE INFUSION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT B. BRAUN AND THE HOSPITAL HAS DETERMINED THIS ISSUE TO BE USER ERROR. THE PUMP LOG SHOWS THE NURSE PROGRAMMED 33.33 AS THE DOSE, NOT THE RATE; THIS EQUATED TO A RATE OF OVER 1,100ML'S/HR.

    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 UNKNOWN Other