BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5520608 · Received March 23, 2016

    Report

    Report Number
    1314492-2016-01904
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 4, 2016
    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
    NY, US
    Reporter Occupation
    OTHER

    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, AUTOMATIC/REPEATED KEYPAD OUTPUT , WHICH WAS REPRODUCED. 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 #4 KEY IS PRESSED 41 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE JKL KEY IS SELECTED, JA 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

    DURING RECERTIFICATION OF A BAXTER PUMP, FUNCTIONALITY TESTING WAS COMPLETED. DURING THE TESTING, THE DEVICE EXPERIENCED AN AUTOMATIC/REPEATED KEYPAD OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176655 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1