BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6043194 · Received October 20, 2016

    Report

    Report Number
    1314492-2016-04944
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 #1 KEY TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #1 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #3 KEY IS PRESSED 31 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE GHI KEY IS SELECTED, GA WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). THE FAILED KEYPAD WAS REPLACED. ADDITIONAL INFORMATION: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD A "DAMAGED KEYPAD". ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695351 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1