BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2923029 · Received December 27, 2012

    Report

    Report Number
    1314492-2012-00537
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. THE DEVICE WAS CONFIRMED TO TURN ON INTERMITTENTLY WITHOUT USER INPUT CAUSED BY A FAILED UPPED HOOK SWITCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP INTERMITTENTLY TURNS ON WITHOUT USER INPUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1