BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3792639 · Received January 2, 2014

    Report

    Report Number
    1314492-2014-00032
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN RELATION TO THE DISCOVERED SYMPTOM, WHICH WAS REPRODUCED. DELAYED KEYPAD RESPONSE WAS CONFIRMED AND WAS DETERMINED TO BE CAUSED BY A FAILED PROCESSOR PRINTED CIRCUIT BOARD (PCB) ASSEMBLY. A DELAYED KEYPAD RESPONSE OF APPROXIMATELY 3 SECONDS WAS OBSERVED DURING TESTING, LIMITING KEYPAD FUNCTIONALITY. THE FAILED PROCESSOR PRINTED CIRCUIT BOARD (PCB) ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS DISCOVERED DURING BAXTER'S TESTING THAT A SPECTRUM PUMP'S KEYPAD HAD A DELAYED RESPONSE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1