BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2273731 · Received September 12, 2011

    Report

    Report Number
    1314492-2011-00051
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 12, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HISTORY LOG WAS EVALUATED TO IDENTIFY THE ROOT CAUSE TO THE REPORTED MEDICATION ERROR. NO DEVICE MALFUNCTION WAS FOUND THAT COULD HAVE CONTRIBUTED TO THE DESCRIBED MEDICATION ERROR. THE HISTORY LOG SHOWS THAT PRIOR TO (B)(6) 2011 AT 21:47 (GMT) THE UNIT WAS PROGRAMMED TO RUN AT 4.2 ML/HR. THE USER THEN REPROGRAMMED THE PUMP BY MANIPULATING THE "TIME, AND "VTBI" PARAMETERS WHICH CHANGED THE DELIVERY RATE TO 3.3ML/HR. THE UNIT RAN UNTIL (B)(6) 2011 22:07 (GMT). ON (B)(6) 2011 AT 22:05 (GMT). THE UNIT WAS THEN AGAIN REPROGRAMMED WHICH CHANGED THE DELIVERY RATE TO 1ML/HR. ONE (B)(6) 2011 AT 00:47 (GMT) THE TITRATE KEY WAS PRESSED AND THE RATE CHANGED TO 4.2ML/HR. THE DEVICE WAS TESTED FOR FLOW RATE ACCURACY AND PASSED. NO DEVICE MALFUNCTION WAS FOUND THAT COULD CONTRIBUTE TO THE DESCRIBED MEDICATION ERROR AND THE HISTORY CONFIRMS THAT THE USER PROGRAMMED THE DELIVERY PARAMETERS THAT WERE DESCRIBED IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MEDICATION ERROR WITH PROGRAF GTT. THE ORDER IS TO RUN A BAG FOR 24 HOURS AT 4.2 CC'S PER HOUR. BUT THE DRIP FOR THE PT WAS RUNNING AT 1CC PER HOUR AND CHARTED ON EMTEK AT 2.4 CC'S PER HOUR ON (B)(6) 2011 (7 PM - 7 AM) AND (B)(6) 2011 (7 AM - 7 PM). THERE WAS NO REPORTED PT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA LLC 3570

    Patients

    Seq Age Sex Outcome Treatment
    1