BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2748003 · Received September 7, 2012

    Report

    Report Number
    1314492-2012-00266
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Report Date
    August 10, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. IT WAS OBSERVED THAT WHEN THE #5 (MNO) KEY IS SELECTED, THE #2 (DEF) KEY IS DISPLAYED. WHEN THE #6 (PQR) KEY IS SELECTED, THE #3 (GHI) KEY IS DISPLAYED. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN #5 ON A PUMP KEYPAD IS SELECTED #2 IS DISPLAYED. IT WAS ALSO REPORTED THAT WHEN #6 IS SELECTED #3 IS DISPLAYED. THE CUSTOMER STATED 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 CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1