BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4463832 · Received July 2, 2014

    Report

    Report Number
    1314492-2014-41020
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM DYSFUNCTIONAL KEYPAD. THE EVALUATION FOUND THAT ALL OF THE KEYS HAD AN INTERMITTENT RESPONSE. THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    I TWAS REPORTED THAT A SPECTRUM INFUSION PUMP HAD A DYSFUNCTIONAL KEYPAD. TI WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388915 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1