BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3060577 · Received March 27, 2013

    Report

    Report Number
    1314492-2013-00298
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THAT THE PUMP WILL TURN OFF WITHOUT USER INPUT APPROXIMATELY 1 SECOND AFTER POWERED ON. FURTHER EVALUATION FOUND THIS TO BE CAUSED BY A FAILED PROCESSOR PRINTED CIRCUIT BOARD (PCB). THE FAILED PROCESSOR PCB WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WILL POWER UP ON AND OFF WITHOUT USER INPUT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124968 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1