BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192515 · Received June 4, 2013

    Report

    Report Number
    1314492-2013-00697
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    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). DURING BAXTER'S EVAL OF THE DEVICE IT WAS DISCOVERED THAT THE #8 AND #9 KEYS WERE INOPERABLE. THIS IS CAUSED BY A FAILED KEYPAD. WHEN ATTEMPTING TO NAVIGATE THROUGH CARE AREA/DRUG SELECTION, AND ATTEMPTING TO INPUT DESIRED PARAMETERS THE FOLLOWING WAS OBSERVED: WHEN ANY OF THE REMAINING FUNCTIONAL KEYS WERE PRESSED AN AUTOMATIC OUTPUT OF THE #9 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. NUMERICALLY: WHEN THE #1 KEY IS PRESSED, 19 WILL BE DISPLAYED, ALPHABETICALLY: WHEN THE "ABC" KEY IS PRESSED, AY WILL BE DISPLAYED INTERFERING WITH MDL DRUG SEARCHING OPPORTUNITIES). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    DURING BAXTER'S EVAL, A DEVICE WAS FOUND TO HAVE A KEYPAD ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247807 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1