BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2114237 · Received June 1, 2011

    Report

    Report Number
    1314492-2011-00024
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBING USED WAS A BAXTER (B)(4) AND A SECONDARY SET WAS ATTACHED. SIGMA'S INVESTIGATION INTO THIS COMPLAINT RESULTED IN THE CONCLUSION THAT THIS WAS A USE ERROR. SIGMA HAS CONTACTED BAXTER TO RELAY THE INCIDENT SO APPROPRIATE FOLLOW UP WITH THE CUSTOMER CAN BE TAKEN. THE PRODUCT WAS NOT RETURNED TO SIGMA FOR INVESTIGATION. IF THE PUMP IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, SIGMA WAS ALERTED ABOUT AN UNSPECIFIED SIGMA SPECTRUM PUMP IN WHICH TUBING WAS LOADED UPSIDE DOWN AND THE PUMP STARTED PULLING BLOOD FROM THE PATIENT. THIS WAS CAUGHT EARLY ON AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION INVOLVING THE PATIENT. THE DATE OF THE EVENT AND SERIAL NUMBER OF THE PUMP ARE UNKNOWN.

    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