BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3932059 · Received February 1, 2014

    Report

    Report Number
    1314492-2014-07270
    Event Type
    Malfunction
    Date Received
    February 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER AND AN EVALUATION COULD NOT BE PERFORMED. IF THE DEVICE IS RETURNED AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS A SYSTEM ERROR 105. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69064 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1