BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2482982 · Received March 2, 2012

    Report

    Report Number
    1314492-2012-00032
    Event Type
    Death
    Date Received
    March 2, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 2, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO INFO WHICH SUGGESTS A MALFUNCTION OCCURRED. THE CUSTOMER HAS REPORTED THAT AN INCORRECT DOSE MODE WAS SELECTED BY THE USER. THE DEVICE WAS NOT RETURNED TO SIGMA FOR EVALUATION AND HENCE AN EVALUATION COULD NOT BE COMPLETED. THE CUSTOMER CANNOT IDENTIFY THE DEVICE INVOLVED IN THE EVENT. IF THE DEVICE IS IDENTIFIED AND RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 A PUMP OVER INFUSED ON A PT. THE HOSPITAL HAS INDICATED THAT OVER INFUSION RESULTED FROM A PROGRAMMING ERROR WHERE UNITS/MINUTE WAS SELECTED INSTEAD OF UNITS/HOUR. THE CAUSE OF DEATH WAS STATED TO BE AN ANEURYSM IN THE CORONARY ARTERY.

    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