BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2315391 · Received October 24, 2011

    Report

    Report Number
    1314492-2011-00067
    Event Type
    Death
    Date Received
    October 24, 2011
    Date of Event
    August 27, 2010
    Report Date
    September 26, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP IN QUESTION HAS NOT BEEN RETURNED TO SIGMA FOR EVALUATION. THE CUSTOMER STATED THAT THEY TESTED THE PUMP FOR FLOW RATE ACCURACY AFTER THE EVENT AND THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. SIGMA'S ASSESSMENT OF THE HISTORY LOG IS AS FOLLOWS: THE SUSPECTED HISTORY LOG ENTRIES ASSOCIATED WITH THE REPORTED EVENT BEGIN AT THE DATE STAMP (B)(6) 2010. THE CARE AREA CHOSEN WAS "(B)(6)" AND THE PUMP WAS PROGRAMMED TO INFUSE 20 ML OF "IV FLUIDS" AT A DELIVERY RATE OF 10 L/HR. IN SUMMARY, THE PUMP ALARMED "AIR-IN-LINE" WITHIN APPROXIMATELY TWO MINUTES INTO THE INFUSION CAUSING THE PUMP TO AUTOMATICALLY STOP TO PREVENT INFUSION OF AIR. A TYPICAL SET PRIMING VOLUME IS 10-20 ML, THEREFORE "AIR-IN-LINE" AFTER INFUSING ONLY 0.1 ML SUGGESTS THAT THE IV SET MAY NOT HAVE BEEN FULLY PRIMED AT THE START OF THE INFUSION. A SECOND "AIR-IN-LINE" ALARM OCCURRED APPROXIMATELY ONE MINUTE AFTER THE INFUSION WAS RESTARTED, SUGGESTING THAT THE PUMP PROPERLY DETECTED AIR AT THE TIME OF THE FIRST "AIR-IN-LINE" ALARM AND THAT AIR REMAINED PRESENT IN THE AIR DETECTOR. IT APPEARS THE USER THEN HAD DIFFICULTY (I.E. FOUR IV SET LOAD ATTEMPTS) OVER THE FOLLOWING 4 MINUTES GETTING THE PUMP TO INFUSE AGAIN. THE INFUSION WAS HALTED AND THE PUMP WAS TURNED OFF 42 MINUTES AFTER THE USER INITIALLY TURNED THE PUMP ON OR 35 MINUTES AFTER THE INFUSION WAS RESTARTED. THE LOG SHOWS THAT 6.1 ML WERE DELIVERED. IT APPEARS THAT PUMP REMAINED IN SERVICE AFTER THIS EVENT AND WAS USED MOST DAYS UNTIL (B)(6) 2010. SIGMA WAS UNAWARE OF THIS INCIDENT PRIOR TO ITS NOTIFICATION FROM THE LAW OFFICES OF (B)(6) ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEONATE WAS BEING TREATED AT (B)(6) HOSPITAL IN (B)(6) IN THE EARLY MORNING HOURS OF (B)(6) 2010. SALINE WAS BEING ADMINISTERED VIA A SIGMA SPECTRUM INFUSION PUMP IN PREPARATION FOR MINOR HERNIA SURGERY. DURING THE PROCESS OF INFUSING THE FLUIDS INTO THE PATIENT AT THAT TIME, AT A RATE THAT THE REGISTERED NURSE IN CHARGE OF THE PATIENT CLAIMED TO BE CONSISTENT WITH APPROPRIATE PRACTICE, THE PUMP WAS NOTED TO READ, "AIR IN LINE" AND SHORTLY THEREAFTER, EMITTED ANOTHER WARNING, "UPSTREAM OCCLUSION." THE PATIENT STOPPED BREATHING, AND EMERGENCY MEASURES WERE UNDERTAKEN BUT THE PATIENT EXPIRED. AN AUTOPSY CONCLUDED THE PATIENT DIED DUE TO AIR IN THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA LLC 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death