BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 2850286 · Received October 24, 2012

    Report

    Report Number
    9610825-2012-00213
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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). (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES. ALL TESTING WAS PERFORMED WITH A VOLUME TO BE DELIVERED OF 558 ML AT 186 ML/H RATE. THE RESULTS WERE ALL WITHIN SPECIFICATION: TEST 1: 563 ML IN 3 HOURS AND 00 MINUTES. TEST 2: 564 ML IN 3 HOURS AND 00 MINUTES. TEST 3: 567 ML IN 3 HOURS AND 00 MINUTES. THE PUMP'S OPERATION LOG WAS REVIEWED. THE INITIAL COMPLAINT REPORT INDICATED THE REPORTED EVENT DATE OCCURRED ON (B)(6) 2012. THE LOG RECORDS START ON (B)(6) 2012; THERE ARE NO RECORDS BEFORE (B)(6) 2012. ON (B)(6) 2012 AT 12:02:54, AN INFUSION WAS STARTED WITH A RATE OF 700.0 ML/H. AT 13:29:35, AN "AIR ALARM" OCCURRED AND THE INFUSION STOPPED WITH A TOTAL VOLUME INFUSED OF 1011.9 ML OR 100.1% OF THE EXPECTED VOLUME. ON (B)(6) 2012 AT 11:59:37, AN INFUSION WAS STARTED WITH A RATE OF 111.0 ML/H. AT 12:19:36, THE INFUSION COMPLETED AND THE PUMP SWITCHED TO KVO (KEEP VEIN OPEN) AT A RATE OF 3.0 ML/H AND A TOTAL VOLUME INFUSED OF 37.0 ML, OR 100.1% OF THE EXPECTED VOLUME. AT 12:20:23, THE PUMP WAS STOPPED. AT 12:20:24, AN INFUSION WAS STARTED WITH THE SAME RATE OF 111.0 ML/H, THEN IMMEDIATELY AT 12:20:27, THE RATE WAS CHANGED TO 400.0 ML/H. AT 12:22:02, WITH A TOTAL VOLUME INFUSED OF 10.7 ML OR 100.9% OF THE EXPECTED VOLUME, THE RATE WAS INCREASED TO 450.0 ML/H. AT 12:23:44, THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 12.7 ML, OR 99.6% OF THE EXPECTED VOLUME. AT 12:23:59, AN INFUSION WAS STARTED WITH A RATE OF 185.0 ML/H. AT 14:13:25, AN "AIR ALARM" OCCURRED AND THE INFUSION STOPPED WITH A TOTAL VOLUME INFUSED OF 337.6 ML, OR 100.1% OF THE EXPECTED VOLUME. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF # (B)(4), SERIAL # (B)(4). INCIDENT OCCURRED (B)(6) 2012. REPORTS UNDER INFUSION / DELAY IN THERAPY, PT NOT INJURED, NO MEDICAL INTERVENTIONS REQUIRED. DRUG ADMINISTERED TAXOL. VOLUME OF APPROXIMATELY 550 TO INFUSE OVER 3 HOURS RATE SET 186/HOUR. AT END OF 3 HOUR PERIOD, PROGRAMMED SETTING COMPLETED BUT ONLY HALF BAG INFUSED. USED A DIFFERENT PUMP TO COMPLETE THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other