BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4696717 · Received January 15, 2015

    Report

    Report Number
    1314492-2015-00596
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 17, 2014
    Report Date
    December 17, 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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE IDENTIFIED "KEYPAD MALFUNCTION" WAS CONFIRMED DURING EVALUATION. EVAL FOUND THE #0, #1 AND #2 KEYS O BE INTERMITTENTLY WORKING CAUSED BY A FAILED KEYPAD. THE FAILED KEYPAD WAS REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S FUNCTIONALITY TESTING IT WAS FOUND THAT A SPECTRUM PUMP HAS A KEYPAD MALFUNCTION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36500 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1