BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3061383 · Received March 26, 2013

    Report

    Report Number
    1314492-2013-00296
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THAT THE PUMP WILL POWER ON WHEN THE DOOR IS MANIPULATED CAUSED BY A FAILED UPPER LATCH SWITCH. THIS IS ALSO THE CAUSE OF THE SLIDE CLAMP ALARM. THE UPPER LATCH SWITCH WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WILL POWER ON WHEN THE CASE IS PRESSED. THE DEVICE ALSO DISPLAYS A SLIDE CLAMP ALARM. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123186 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1