BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 6053677 · Received October 25, 2016

    Report

    Report Number
    9610825-2016-00682
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 13, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM USER FACILITY TO BBM LABORATORY IN MELSUNGEN, GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): SYSTEM ALERT: "THE PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE IN FULL ANAESTHESIA. DURING THE PROCEDURE THE INFUSION PUMP, WHICH WAS RUNNING IN TCI MODE, GAVE TWO TIMES AN ALARM FOR "LID OPEN", BUT AFTER PAUSING THE INFUSION AND OPENING AND CLOSING THE LID THE ALARM WAS CANCELLED. AT THE END OF THE SURGICAL PROCEDURE THE RESPECTIVE ALARM APPEARED FOR THE THIRD TIME TOGETHER WITH THE NOTIFICATION OF "SYSTEM ALERT" AND A RED BLINKING LIGHT IN THE DISPLAY. THE ANAESTHESIA WAS CONTINUED AND COMPLETED BY USING AN INHALED ANAESTHETIC IN COMBINATION WITH SEDATING DRUG. NO HARM TO THE PATIENT WAS REPORTED."

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). RESULT OF EXAMINATION: A VISUAL INSPECTION WAS PERFORMED. THE PUMP WAS CLEAN AND SHOWED NO DAMAGE. THE COVER CAPS ON THE SCREW PILLARS AS WELL AS THE SEAL ON THE LOWER HOUSING WERE AVAILABLE AND UNDAMAGED. THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THERE WAS NO DATE OF OCCURRENCE, THEREFORE THE LAST THERAPY WAS ANALYZED. A DEVICE ALARM 2114 OCCURRED ON THE 10TH OF OCTOBER DIRECTLY AFTER THE RESTART OF THE INFUSION DURING A TCI - THERAPY. NO OTHER ABNORMALITIES WERE ASSESSED. A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST WITH A POSITIVE RESULT. THE SPACE LINE, WHICH WAS INSERTED FOR TECHNICAL PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. IT WAS TRIED TO REPRODUCE THE DEVICE ALARM 2114. A TCI THERAPY WAS STARTED AND A FLOW ALARM WAS TRIGGERED. THE ALARM WAS QUIT AND THE PUMP WAS RESTARTED. THIS WAS REPEATED OVER 30 TIMES. DURING THIS TEST NO MALFUNCTION OCCURRED. THE ALARM COULD NOT BE REPRODUCED. THE SAMPLE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. NO ABNORMALITIES WERE ASSESSED. THE COMPLAINT IS NOT JUDGABLE. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATED WITHIN OUR SPECIFICATION. THE DEVICE ALARM 2114 OCCURRED ONCE AND IT WAS NOT REPRODUCIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705488 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1