BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM PUMP

    MDR report key: 1557564 · Received April 23, 2009

    Report

    Report Number
    1314492-2009-00004
    Event Type
    Other
    Date Received
    April 23, 2009
    Date of Event
    March 4, 2009
    Report Date
    April 23, 2009
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT (B)(4) WAS RECEIVED ON MARCH 30, 2009 REGARDING AN ADVERSE EVENT/PRODUCT PROBLEM REPORTED BY (B)(6) TO THE FDA ON (B)(6) 2009. ALL OF SIGMA'S INTERNAL DATABASES HAVE BEEN EXTENSIVELY SEARCHED AND CROSS-REFERENCED AND THERE IS NOT A RECORD OF THIS REPORTED EVENT. NUMEROUS ATTEMPTS TO CONTACT THE INITIAL REPORTER OF THE EVENT HAVE BEEN MADE IN ORDER TO COLLECT MORE SPECIFIC INFO OF THE REPORTED EVENT. TO DATE, THE COMPLAINT HAS NOT RESPONDED. THE INFO WE RECEIVED, DOES NOT PROVIDE ADEQUATE INFO TO CONDUCT A MORE THOROUGH INVESTIGATION OF THE REPORTED EVENT. THE PUMP SERIAL NUMBER, MODEL NUMBER AND THE ALARM TYPE HAS NOT BEEN PROVIDED IN REPORT (B)(4). THE ONLY INFO CONCERNING THE PUMP THAT WAS PROVIDED WAS A MODEL NUMBER OF 052308, WHICH IS NOT CONSISTENT WITH OUR PRODUCT LINE. ONCE MORE DETAILS OF THE EVENT CAN BE PROVIDED, WE ARE UNABLE TO CONDUCT AN ADEQUATE INVESTIGATION INTO THE REPORTED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A NICARDIPINE DRIP INFUSION, THE PUMP DISPLAYED AN ERROR MESSAGE ON THE SCREEN, BUT DID NOT ALARM. THE MEDICATION WAS NOT INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM PUMP INFUSION PUMP FRN SIGMA LLC 35700 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1