BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2934139 · Received December 21, 2012

    Report

    Report Number
    1314492-2012-00527
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THE FIFTH ROW OF KEYS TO HAVE THE SAME OUTPUT AS THE FOURTH ROW OF KEYS ON THE KEYPAD. THE #7 (STU) KEY WILL HAVE THE ALPHA NUMERIC OUTPUT OF THE #4 (JKL) KEY. THE #8 (VWX) KEY WILL HAVE THE ALPHA NUMERIC OUTPUT OF THE #5 (MNO) KEY AND THE #9 (YZ) KEY WILL HAVE THE ALPHA NUMERIC OUTPUT OF THE #6 (PQR) KEY. FURTHER EVAL FOUND THAT THIS WAS DUE TO A FAILED KEYPAD. ADDITIONALLY, IT WAS OBSERVED THAT THE POWER CORD ASSEMBLY FAILED. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP KEYPAD IS INOPERABLE AND THAT THE POWER DOES NOT WORK. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1