BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION UMP

    MDR report key: 2922673 · Received December 27, 2012

    Report

    Report Number
    1314492-2012-00542
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SIGMA DEVICE EVAL FOUND THE #2, #3, #4, #5, #6, #7, #8, #9 AND (.) KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #3 KEY WILL OCCUR FOLLOWING THE SELECTED KEY¿S FUNCTION (E.G. WHEN THE #1 KEY IS PRESSED 13 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE ¿ABC¿ KEY IS SELECTED, AG WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). SIGMA¿S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #3 KEY ON A PUMP KEYPAD IS "STUCK." THE CUSTOMER ALSO STATED THAT THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1