BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2237202 · Received September 2, 2011

    Report

    Report Number
    9610825-2011-00122
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 1, 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
    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), AND B. BRAUN MEDICAL, INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (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 (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 PUMP LOG WAS REVIEWED AND IT INDICATED THAT THE REPORTED DOPAMINE INFUSION WAS INITIALLY SET TO RUN A DOSE RATE OF 1.999 MCG/KG/MIN AT 10:48:53 ON (B)(6) 2011, (RATE 7.12ML/HR) WITH A VOLUME TO BE INFUSED (VTBI) OF 250ML. THE INFUSION STARTED AT 10:51:07 AND CONTINUED UNTIL 12:38:46, AT WHICH TIME THE DOSE RATE WAS MANUALLY CHANGED TO 1.008 MCG/KG/MIN (RATE 3.59ML/HR). THE INFUSION THEN PROCEEDED AT THIS LOWER RATE UNTIL 4:00:29 ON (B)(6) 2011. THE TOTAL VOLUME INFUSED FOR THE 1.999 MCG/KG/MIN DOSE RATE SETTING WAS 12.77ML, OR 100.65 OF EXPECTED VOLUME AND THE VOLUME INFUSED FOR 1.008 MCG/KG/MIN DOSE RATE WAS 55.15ML, OR 99.9% OF EXPECTED VOLUME. THESE RESULTS WERE BOTH WITHIN SPECIFICATION. VOLUMETRIC ACCURACY WAS ALSO TESTED THREE TIMES AT A RATE OF 250ML/HR AND A VTBI OF 25ML USING THE CUSTOMER BAG AND LINE RETURNED WITH THE PUMP. IN ALL THREE INSTANCES, THE PUMP OPERATED WITHIN SPECIFICATION AND DELIVERED THE TARGET VOLUME WITH RESULTS OF 25.1ML, AND 25.0ML, AND 25.1ML, RESPECTIVELY. UPSTREAM AND DOWNSTREAM OCCLUSIONS WERE ALSO INDUCED AND THE PUMP ALARMED AS EXPECTED. IN ADDITION TO THE TESTING THAT WAS CONDUCTED ON THE RETURNED PUMP, VARIOUS LOT NUMBERS OF INFUSOMAT SPACE PUMP IV TUBING SETS (B. BRAUN (B)(4)) 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 RESULTS OF THIS INVESTIGATION, THERE WERE NO ABNORMALITIES NOTED WITH THE OPERATION OF THE PUMP RETURNED. WHEN COMPARING THE LOG REVIEW WITH THE REPORTED EVENT, THE INFUSION RATE WAS DECREASED FROM THE REPORTED DOSE RATE OF 2.0 MCG/KG/MIN TO HALF THE RATE (1.008 MCG/KG/MIN), WHICH IS CONSISTENT WITH AND COULD ACCOUNT FOR THE REPORTED UNDER-INFUSION WHEN IT WAS PERCEIVED THE PUMP WAS INFUSING AT A HIGHER RATE. FURTHERMORE, 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: UNDER INFUSED. NO PATIENT INJURY. THE RN STATED: "ASSUMED CARE OF THE PATIENT 0700. UPON ASSESSMENT OF THE IV MEDICATION AT 0815 WITH MD AT BEDSIDE, NOTICED THE BAG OF DOPAMINE WAS FULL ALTHOUGH THE PUMP WAS RUNNING. MD INQUIRED IF THE BAG WAS NEW. I LOOKED AT THE LABEL ON THE BAG AND FOUND THAT IT WAS HUNG AT 0800 ON (B)(6) 2011 WITH THE PRIOR DAY'S RN'S INITIALS ON THE BAG. VERIFIED THE PUMP WAS ON AND RUNNING AND SET PROPERLY AT 2MCG/KG/MIN. FURTHER VERIFIED THAT THE PUMP WAS NOT ALARMING. I IMMEDIATELY SEQUESTERED THE PUMP, TUBING AND BAG AND SENT TO BIOMED."

    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