BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3801725 · Received January 8, 2014

    Report

    Report Number
    1314492-2014-01361
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYMPTOM INTERMITTENT KEYPAD WAS CONFIRMED AND REPRODUCED. IT WAS FOUND THAT ROW 3, KEYS #0, #1, #2 AND #3 WERE INTERMITTENTLY FUNCTIONING. THIS WAS CAUSED BY A FAILED KEYPAD. AS A RESULT, THE KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP'S KEYPAD HAD AN INTERMITTENT RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11995 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1