BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4875757 · Received June 24, 2015

    Report

    Report Number
    1314492-2015-07058
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    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). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, WHICH WAS REPRODUCED. THE DEVICE EVALUATION CONFIRMED THE #2, #3, (.), #4, #5, #6, #7, #8, AND #9 KEYS O BR INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AND 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). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD A "STUCK '3' KEY". IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407811 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1