BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5284851 · Received December 10, 2015

    Report

    Report Number
    1314492-2015-11674
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    October 1, 2015
    Report Date
    November 18, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. DURING EVALUATION IT WAS IDENTIFIED THAT THE MECHANISM ASSEMBLY INSTALLED INTO THE DEVICE (923507) DID NOT MATCH THE MECHANISM RECORDED ON THE DEVICE HISTORY RECORD (DHR) . REVIEW OF BOTH DHRS CONFIRMED THAT THE MECHANISM WAS SWAPPED AND BELONGED TO SERIAL NUMBER (B)(4). THIS IS AN INDICATION THAT THE MECHANISM IS NOT ORIGINAL TO THE DEVICE AND WAS INSTALLED OUTSIDE THE FACTORY, AN OPERATION THAT IS NOT PERMITTED. THIS UNAUTHORIZED REPAIR PERFORMED OUTSIDE THE FACTORY EXPOSED THE INTERNAL ESD SENSITIVE COMPONENTS, COMPROMISING ALL INTERNAL ELECTRICAL COMPONENTS RENDERING THE UNIT IRREPARABLE. IN THE WARNINGS AND CAUTIONS OF THE SPECTRUM OPERATORS MANUAL, IT STATES ""SERVICING THE SIGMA SPECTRUM INFUSION SYSTEM IS RESTRICTED TO QUALIFIED, SIGMA TRAINED, SERVICE PERSONNEL WHO EMPLOY SIGMA AUTHORIZED PARTS AND PROCEDURES. USE OF OTHER PARTS AND SERVICING PROCEDURES IS PROHIBITED."" THE DEVICE COULD NOT BE REPAIRED AND HAS BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION OF A SPECTRUM PUMP, EVIDENCE OF TAMPERING/UNAUTHORIZED SERVICE WAS FOUND. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT WITH THE DEVICE AFTER THE UNAUTHORIZED SERVICE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817134 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1