BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA

    MDR report key: 2344229 · Received November 15, 2011

    Report

    Report Number
    MW5023136
    Event Type
    Injury
    Date Received
    November 15, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 2, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SIGMA SPECTRUM PUMP WAS INFUSING DOBUTAMINE IV-A 500 ML BAG. WHEN THE MEDICATION WAS INITIATED AT 11:20AM, 2 NURSES CHECKED THE IV, PUMP PROGRAMMING AND MEDICATION DOSAGE. THE MEDICATION WAS TO RUN 1.3ML/HR. APPARENTLY 2/3 OF THE IV INFUSED INTO THE PT, THE PT HAD A CARDIAC ARREST AT 11:48AM, AND WAS SUCCESSFULLY RESUSCITATED BUT THERE WAS ONLY 50CC LEFT IN THE 500ML IV BAG AT THAT TIME. WE ARE ASSUMING THIS "MAY" HAVE BEEN A PUMP MALFUNCTION. ADDENDUM REPORT: I HAD PREVIOUSLY REPORTED A PUMP PROBLEM ON (B)(4) 2011. THE SIGMA PUMP WAS THOUGHT TO DELIVER A LARGE AMOUNT OF A MEDICATION (DOBUTAMINE) TO THIS PT CAUSING THE PT TO ARREST. AT THE TIME WE THOUGHT THE PUMP HAD MALFUNCTIONED. I WOULD LIKE TO CLARIFY THAT AFTER ADD'L INVESTIGATION AND PULLING THE INFUSION HISTORY ON THE PUMP WE HAVE REASON TO BELIEVE THAT THIS WAS A USER ERROR PROBLEM AND NOT THE IV PUMP PROBLEM THAT WAS PREVIOUSLY REPORTED. WE ARE CONTINUING TO EVALUATE THIS PUMP WITH THE MFR. THANK YOU.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R