BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3173095 · Received May 30, 2013

    Report

    Report Number
    1314492-2013-00669
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM. THE DELAY OBSERVED WAS APPROXIMATELY THREE SECONDS, AND CAUSED BY A FAILED PROCESSOR PRINTED CIRCUIT BOARD. THE KEYPAD WAS PERFORMANCE TESTED AND ALL KEYS WERE FOUND TO FUNCTION AS DESIGNED, WITH NO INCORRECT KEYPAD OUTPUT ANOMALIES. THE DEVICE WAS NOT OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE KEYPAD WAS REPLACED AND THE DEVICE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, REGARDING THE KEYPAD ON A PUMP, WHEN A KEY IS PRESSED, THERE IS A DELAY OF UP TO 5 SECONDS BEFORE THE PUMP ACKNOWLEDGES THAT A BUTTON HAS BEEN PUSHED. IT WAS ALSO REPORTED THAT THE ISSUE WAS DISCOVERED DURING ROUTINE CLEANING AND MAINTENANCE, AND THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238717 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1