BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921401 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06538
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL CONFIRMED AND REPRODUCED THE DISCOVERED SYMPTOM OF A STUCK KEYPAD KEY. EVAL FOUND ALL KEYS INOPERABLE EXCEPT THE ON/OFF KEY DUE TO A STUCK 2ND SOFT KEY, AND WAS CAUSED BY A FAILED KEYPAD. THE KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TP FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    DURING BAXTER'S DEVICE EVAL, IT WAS DISCOVERED THAT A SPECTRUM PUMP HAD A STUCK KEY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78600 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1