BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2769127 · Received September 26, 2012

    Report

    Report Number
    9610825-2012-00186
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 3, 2012
    Report Date
    September 26, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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) (THE MANUFACTURER), AND (B)(4) (THE IMPORTER). (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT OF PUMP STOPPING WITHOUT ALARM WAS NOT CONFIRMED. THE COMPLAINT OF A BLANK SCREEN WAS CONFIRMED, HOWEVER, THIS DID NOT AFFECT THE VOLUMETRIC OPERATION OF THE PUMP. THE OCCLUSION AND KVO ALARM FUNCTIONS WERE TESTED WITH THE BLANK SCREEN AND THE ALARMS FUNCTIONED EVEN WITH THE BLANK SCREEN. THE PUMP WAS THEN RUN FOR 24 HRS WITH THE BLANK SCREEN AND THE PUMP RAN CORRECTLY WITH NO ALARMS OR INTERRUPTIONS. THE OPERATING UNIT WITH LCD SCREEN AND UPGRADED METAL FRONT SHEET WAS REPLACED. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2012 AT 4:28:35 PM, A NEW DOSE RATE OF 14.980 MICROGRAM/KGKG/MINUTE AND A NEW RATE SET OF 7.29 ML/H WERE ENTERED. AT 4:28:38 PM, THE INFUSION WAS STARTED. AT 4:48:18 PM, THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 2.39 ML OR 100.0% OF THE EXPECTED VOLUME. AT 4:48:20 PM, THE INFUSION WAS RE-STARTED WITH THE SAME RATE OF 7.29 ML/H. AT 4:48:32 PM, THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 0.03 ML OR 123.0% OF THE EXPECTED VOLUME (DEVIATIONS (B)(4) ARE NOT UNUSUAL FOR INFUSIONS WITH A RATE OF <25 ML/H AND LESS THAN 2 MIN DURATION). AT 4:48:33 PM, THE PUMP WAS PLACED ON 'STANDBY' AND AT 4:48:37 PM, THE PUMP WAS TAKEN OUT OF 'STANDBY'. AT 4:48:49 PM AND AT 4:49:00 PM, THE 'HINT; STANDBY DENIED' MESSAGE ALARM WAS ACTIVATED. AT 4:49:02 PM, THE "HINT; START IN MAIN MENU" MESSAGE ALARM WAS ACTIVATED. AT 4:53:05 PM, THE "HINT; ALARM CONFIRMED" MESSAGE WAS ACTIVATED. AT 4:53:34 PM, THE PUMP WAS DISCONNECTED FROM THE AC OUTLET. AT 4:58:17 PM AND 4:58:28 PM, THE "BATTERY COVER OPEN; ON" MESSAGE ALARM WAS ACTIVATED. AT 4:58:31 PM, THE MESSAGE ALARM WAS TURNED OFF. AT 4:58:49 PM, THE "HINT; STANDBY DENIED" MESSAGE ALARM WAS ACTIVATED AND AT 5:13:01 PM, THE MESSAGE ALARM WAS TURNED OFF. AT 5:13:04 PM AND 5:13:37 PM, THE "HINT; STANDBY DENIED" MESSAGE WAS ACTIVATED AND AGAIN ONE LAST TIME AT 5:51:27 PM, ON (B)(6) 2012. PER THE OPERATIONAL LOG, THERE IS NO INDICATION A MALFUNCTION OR FAILURE OCCURRED THAT WOULD HAVE GENERATED ANY SYSTEM ALARM. THE LOG SHOWS THE PUMP WAS PROPERLY STOPPED BY THE USER DURING THE LAST INFUSION ACTIVITY AT 4:48:32 PM. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFO BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4). INCIDENT DATE: (B)(6) 2012 AT 4:30 PM. WHILE ADMINISTERING PROPOFOL, THE THERAPY DELAYED WITHOUT ALARM AND SCREEN WENT BLACK AND PUMP STOPPED PUMPING. NO AUDIBLE ALARM WENT OFF. THE BIOMED DEPT WAS ABLE TO DUPLICATE, DISPLAY WENT BLANK AND PUMP STOPPED WITH NO ALARM DURING TEST AFTER ABOUT 10 HOURS. THEIR TECH IS ALSO CONCERNED BECAUSE THE LOGS DON'T SHOW THE TEST RUN THEY DID AT ALL. NO PT INJURY.

    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