BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2546133 · Received April 20, 2012

    Report

    Report Number
    1314492-2012-00055
    Event Type
    Death
    Date Received
    April 20, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 23, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA PERSONNEL VISITED THE CUSTOMER TO FURTHER INVESTIGATE THE EVENT. INITIAL EVAL OF THE DEVICE IN QUESTION AND HISTORY LOG REVEALED THAT THE PUMP WAS NOT CONFIGURED TO THE HOSPITALS NETWORK, THEREFORE THE FACILITIES MEDICAL DRUG LIBRARY WS NOT MADE AVAILABLE TO THIS DEVICE. THIS CAUSE THE DEVICE TO ONLY BE OPERABLE IN "BASIC MODE". A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN DESIGN SPEC. ADDITIONALLY, UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. NO DEVICE MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER COULD NOT PROGRAM A PUMP TO DELIVER DOPAMINE TO A PT. THE USER WAS UNABLE TO LOCATE THE REQUIRED CARE AREA AND WAS NOT FAMILIAR WITH PROGRAMMING THE DEVICE IN "BASIC MODE", THE INFUSION WAS DELAYED UNTIL THE PT WAS TRANSFERRED TO ICU AND A DIFFERENT PUMP COULD BE UTILIZED. THE CUSTOMER STATED THAT AFTER THE INFUSION RECOMMENCED, THE PT'S BLOOD PRESSURE WAS STABILIZED. THE PT EXPIRED HOURS LATER.

    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