BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4022806 · Received March 13, 2014

    Report

    Report Number
    1314492-2014-14462
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). DURING BAXTER'S EVALUATION, THE DELAYED KEYPAD RESPONSE WAS CONFIRMED AND WAS REPRODUCED. EVALUATION FOUND THAT THE DELAY IN RESPONSE WAS 3 SECONDS, CAUSED BY A FAILED PROCESSOR PRINTED CIRCUIT BOARD. THE FAILED PROCESSOR PRINTED CIRCUIT BOARD WAS REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S FUNCTIONALITY TESTING IT WAS FOUND THAT A SPECTRUM PUMP EXPERIENCED A DELAYED KEYPAD RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151789 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1