BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM

    MDR report key: 4026954 · Received August 19, 2014

    Report

    Report Number
    4026954
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BAXTER HEALTHCARE INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAVENOUS (IV) HEPARIN WAS INFUSING. THE NURSE LAST CHECKED/VERIFIED THAT THE MEDICATION WAS INFUSING AT 0430. WHEN STAFF WENT INTO THE PATIENT'S ROOM AT 0640, THE PUMP WAS TURNED OFF. THE PATIENT WAS UNSURE HOW OR WHEN IT WAS TURNED OFF. NO ALARMS SOUNDED. ALL STAFF ON THE NURSING UNIT DID NOT TOUCH THE PUMP. STAFF WERE UNABLE TO DETERMINE OUT HOW/WHY THE PUMP WAS IN STANDBY MODE. THE PUMP WAS IN ANESTHESIA MODE. A REPLACEMENT PUMP WAS ORDERED AND THE MALFUNCTIONING PUMP WAS REMOVED FROM SERVICE AND RETURNED TO THE OUTSIDE AGENCY RENTAL COMPANY. THIS FACILITY HAS REQUESTED A COPY OF THE SERVICE REPORT ON THE PUMP, BUT HAVE NOT RECEIVED IT TO-DATE. THE PATIENT HAD A RECHECK OF BLOOD TESTS RELATED TO HEPARIN ADMINISTRATION, BUT HAD NO INJURY RELATED TO THE OMISSION OF THE HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500100 SIGMA SPECTRUM PUMP, INFUSION FRN BAXTER HEALTHCARE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR