BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3871340 · Received January 29, 2014

    Report

    Report Number
    1314492-2014-05004
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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. A 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 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
    63779 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1