BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM PUMP

    MDR report key: 1469091 · Received September 11, 2009

    Report

    Report Number
    1314492-2009-00008
    Event Type
    Other
    Date Received
    September 11, 2009
    Date of Event
    May 27, 2009
    Report Date
    September 3, 2009
    Manufacturer
    SIGMA LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, IT WAS DETERMINED THE PUMP DID NOT MALFUNCTION. THE INCIDENT WAS RELATED TO OPERATOR ERROR. THE NURSE AT (B)(6) MEDICAL CENTER DECIDED TO USE THE SIGMA BASIC MODE, WHERE A MEQ/KG/HR DOSE MODE IS AVAILABLE WITHOUT DOSE RATE LIMITS. AS A RESULT, THE NURSE ACCIDENTLY PROGRAMMED IN A 1.5 MEQ/KG/HR RATHER THAN 0.15 MEQ/KG/HR. THIS DEVICE WAS MANUFACTURED USING SOFTWARE (B)(4), WHICH ALLOWS THE USER TO ACCESS THE BASIC MODE WHEN THE MDL SOFTWARE DOES NOT CONTAIN THE REQUIRED DRUG, OR THE OPERATOR CHOOSES NOT TO USE THE MDL SOFTWARE FOR THE INFUSION. SIGMA HAS SINCE RELEASED SOFTWARE (B)(4), WHICH PROVIDES A "CAUTION" MESSAGE WHEN SELECTING BASIC MODE TO ALERT THE USER THEY ARE PROGRAMMING IN BASIC. (B)(6) MEDICAL CENTER HAS SINCE BEEN SERVICED AND PROVIDED THE NEW SOFTWARE (B)(4), WHICH HAS THE "CAUTIONARY" DISPLAY WHEN OPERATING IN BASIC. IN EITHER CASE, BASIC MODE ALLOWS THE USER TO PROGRAM DOSE RATES. THIS IS A TYPICAL FEATURE FOR ALL INFUSION PUMPS.

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED AT (B)(6) IN (B)(6) INVOLVING THE SIGMA SPECTRUM PUMP. A PT REQUIRED A CONTINUOUS INFUSION OF POTASSIUM CHLORIDE OF 0.05MEQ/KG/HR. THIS WAS GIVEN ON A SMITH'S MEDICAL MEDFUSION 3500 PUMP USING THE PICU DRUG LIBRARY AND A POTASSIUM CONCENTRATION OF 1 MEQ/ML. THE POTASSIUM DOSE OF 0.05MEQ/KG/HR EQUALED 1 MEQ/ML. THE DOSE WAS INCREASED TO 0.1MEQ/KG/HR AFTER 24 HOURS WHEN THE POTASSIUM WAS STILL LESS THAN 3.0. THE DOSE WAS INCREASED TO 0.15 MEQ/KG/HR AFTER SOMETIME OF THE POTASSIUM REMAINING LESS THAN 3.0, BUT THIS EQUALED A RATE OF 6 MLS/HR. WHEN THIS RATE QUICKLY USED UP THE 50 ML SYRINGE VOLUME, THE NURSE AND PHARMACIST MADE A NEW DRIP, BUT IN A BAG SO, A 24 HR VOLUME COULD BE DISPENSED. A SIGMA PUMP NEEDED TO BE USED, BUT THE SIGMA PUMP LIBRARY DID NOT HAVE A POTASSIUM OPTION FOR MEQ/KG/HR, ONLY A MEQ/HR OPTION. THE NURSE DECIDED TO USE THE SIGMA BASIC LIBRARY WHERE A MEQ/KG/HR OPTION IS AVAILABLE (WITHOUT LIMITS). UNFORTUNATELY, THE NURSE ACCIDENTLY PROGRAMMED IN 1.5 MEQ/KG/HR RATHER THAN 0.15 MEQ/KG/HR. THE MISTAKE WAS NOT CAUGHT UNIT THE PT CODED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM PUMP INFUSION PUMP FRN SIGMA LLC. 35700 703638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention