BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2864668 · Received November 9, 2012

    Report

    Report Number
    1314492-2012-00408
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. THE UNIT WAS TESTED FOR 24 HOURS AND NO KEYPAD OUTPUT RESPONSE ANOMALIES WERE APPARENT OR OBVIOUS IN THE HISTORY LOG. ALL KEYS PERFORMED AS EXPECTED AND NO KEYS RESULTED IN AN INCORRECT RESPONSE OR DOUBLE ENTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #8 KEY ON A PUMP KEYPAD STICKS AND ENTERS MULTIPLE TIMES WITH EACH SELECTION. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1