BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4973331 · Received August 5, 2015

    Report

    Report Number
    1314492-2015-08351
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE DELAYED KEYPAD RESPONSE, WHICH WAS EXPERIENCED DURING EVALUATION. IT WAS FOUND TO BE CAUSED BY A FAILING PROCESSOR PRINTED CIRCUIT BOARD (PCB). THE FAILED PROCESSOR PCB WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION OF A SPECTRUM PUMP, A DELAYED KEYPAD RESPONSE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518812 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1