BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2682560 · Received July 13, 2012

    Report

    Report Number
    1314492-2012-00131
    Event Type
    Death
    Date Received
    July 13, 2012
    Date of Event
    March 26, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA WAS UNAWARE OF THIS EVENT PRIOR TO RECEIVING AN FDA REQUEST FOR ADD'L INFO ON (B)(4) 2012, INCLUDING A REDACTED USER FACILITY REPORT ((B)(4)). THE CUSTOMER IS UNK AND, CONSEQUENTLY SIGMA HAS BEEN UNABLE TO OBTAIN ADD'L EVENT INFO. SIGMA'S INVESTIGATION IS IN PROGRESS, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED BY (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP OVER INFUSED EPINEPHRINE TO A PT. THE PUMP WAS PROGRAMMED TO DELIVER 2 MCG/MIN AND AFTER AN UNK AMOUNT OF TIME, IT WAS OBSERVED THAT THE DEVICE WAS DELIVERING AT 150 CC/MIN (APPROX 40 MCG/MIN). THE CUSTOMER STATED THAT THE DOSE RATE CHANGE OCCURRED WITHOUT OPERATOR PUMP INTERVENTION DURING TRANSPORT FROM THE OPERATING ROOM TO THE CARDIAC INTENSIVE CARE UNIT. THE PT BECAME HYPOTENSIVE AND ACIDOTIC. THIS CONDITION WAS CORRECTED USING MEDICAL INTERVENTION WITH THE ADMINISTRATION OF A BICARB SOLUTION AND RESETTING THE EPINEPHRINE TO 2 MCG/MIN. AFTER SEVERAL DAYS OF IMPROVEMENT, THE PT EXPERIENCED A CARDIAC ARREST AND EXPIRED. ACTUAL CAUSE OF DEATH IS UNK AT THIS TIME.

    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