BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3198807 · Received June 18, 2013

    Report

    Report Number
    9610825-2013-00176
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). MULTIPLE EVENTS TO THE FACILITY TO OBTAIN ADDITIONAL INFO HAVE NOT BEEN SUCCESSFUL. THE PUMP HAS SOFTWARE VERSION 686G030102. (B)(4). THE PUMP'S OPERATIONAL LOG WAS REVIEWED. SINCE THE OCCURRENCE IS NOT PROVIDED BY CUSTOMER, AND THE VOLUME AND RATE AS STATED IN THE COMPLAINT WERE ALSO NOT IN THE LOG, THE LOG REVIEW WAS PERFORMED FROM THE LAST DAY OF INFUSION ACTIVITY OCCURRED PRIOR TO THE DAY CUSTOMER INITIATED THE COMPLAINT. THAT DAY IS (B)(6) 2013. ON (B)(6) 2013 AT 12:13:03 AM NEW VTBI (VOLUME TO BE INFUSED) WAS SET OF 100 ML, AT THE SAME TIME THE INFUSION WAS STARTED AT THE PREVIOUS RATE OF 240 ML/H. THE INFUSION WAS STOPPED AT 12:24:53 AM WITH 47.28 ML INFUSED OR 100% OF EXPECTED VOLUME. AT 12:25:04 AM NEW VTBI WAS SET OF 15 ML. AT 12:25:06 THE INFUSION WAS STARTED AT THE PREVIOUS RATE OF 240 ML/H. THE INFUSION WENT ON UNTIL THE VTBI WAS COMPLETED AND AUTOMATIC TURN OVER KVO AT 12:28:51 AM WITH 15 ML INFUSED OR 100% OF EXPECTED VOLUME. THE INFUSION WAS STOPPED WHEN THE KVO WAS DONE 12:31:49 AM. AT 12:32:05 AM THE NEW VTBI WAS SET OF 50 ML. THE PUMP SAT IDLING UNTIL 12:36:00 THE INFUSION WAS STARTED AT THE SAME RATE OF 240 ML/H. THE INFUSION WAS STOPPED AT 12:42:06 AM WITH 24.34 ML INFUSED OR 100% OF EXPECTED VOLUME. AT 12:42:33 AM THE INFUSION WAS STARTED, AND STOPPED AT 12:42:37 DUE TO THE UPSTREAM ALARM WAS ON, 0.27 ML INFUSED. PER THE USER MANUAL VOLUMETRIC ACCURACY OF (B)(4) IS ONLY GUARANTEED FOR INTERVALS OF (B)(4) AT A RATE OF (B)(4). THE ALARM WAS CONFIRMED AT 12:42:58 AM. AT 12:43:06 AM NEW RATE WAS SET OF 570 ML/H AND VTBI WAS SET OF 565.3 ML AT ALMOST THE SAME TIME. AT 12:43:16 AM THE INFUSION WAS STARTED. THE INFUSION WENT ON UNTIL THE VTBI WAS COMPLETED AND AUTOMATIC TURN OVER KVO AT 1:42:47 AM. THE 565.3 ML INFUSED OR 100% OF EXPECTED VOLUME. THE INFUSION WAS STOPPED WHEN THE KVO WAS DONE AT 1:44:13 AM. AT 1:44:24 AM NEW RATE WAS SET OF 630 ML/H. NEW VTBI WAS SET OF 2220 ML. AT 1:44:33 AM THE INFUSION WAS STARTED. THE INFUSION WENT ON UNIT THE VTBI WAS COMPLETED AND AUTOMATIC TURN OVER KVO AT 2:05:30 AM WITH 220 ML INFUSED OR 100% OF EXPECTED VOLUME. THE INFUSION WAS STOPPED WHEN THE KVO WAS DONE AT 2:07:23 AM. THE PUMP WAS NOT USED FOR THE REST OF THE DAY AND WAS TURNED OFF AT 2:10:30 AM. WITHOUT THE ACTUAL EVENT DATE, FURTHER INVESTIGATION WAS NOT POSSIBLE. 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 INFO HAS BEEN FORWARDED TO THE DEVICE MFR, IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275685 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1