BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM SMART PUMP

    MDR report key: 2475299 · Received February 28, 2012

    Report

    Report Number
    MW5024453
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 14, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED WITH COMPLAINTS OF WORSENING ANGINA AND DYSPNEA ON EXERTION. THE PT HAS A HISTORY OF CAD AND HAD A CABG IN 1995. THE PT HAD A CARDIAC CATHETERIZATION WHICH SHOWED SEVERE MULTIVESSEL NATIVE CORONARY DISEASE WITH 3 OUT OF 4 BYPASS GRAFTS OCCLUDED. SHE HAD MECHANICAL THROMBECTOMY, BALLOON ANGIOPATHY AND STENTING DONE AND WAS STARTED ON AN INTEGRILIN DRIP. THE PT WAS ADMITTED TO A TELEMETRY UNIT WITH THE INTEGRILIN INFUSING. A PCA ENTERED THE PT'S ROOM AND FOUND THE SIGMA PUMP ALARM GOING OFF. SHE SILENCED THE ALARM AND WENT TO GET THE NURSE. WHEN THE NURSE ENTERED THE ROOM, SHE FOUND THE SIGMA PUMP WITH THE INTEGRILIN INFUSING OFF. WHEN SHE TURNED THE PUMP ON, THE SETTINGS HAD BEEN ERASED. IT IS UNCLEAR IF THE PUMP WAS CHANGED AT THAT TIME BUT DID REMAIN IN THE PT'S ROOM UNTIL IT WAS RETRIEVED THE NEXT DAY BY THE BIOMEDICAL ENGINEER. THE PT DID CONTINUE ON THE INTEGRILIN BUT MISSED 1 HOUR OF MEDICATION. THE PHYSICIAN WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM SMART PUMP SIGMA SMART PUMP FRN SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other