BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4752514 · Received May 1, 2015

    Report

    Report Number
    1314492-2015-05593
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 8, 2015
    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 Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    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 FOLLOWING KEYS ARE INOPERABLE: #2, #3, (.), #4, #5, #6, #7, #8 AND #9 KEY CAUSED BY A FAILED KEYPAD. WHEN ANY OF THE REMAINING FUNCTIONAL KEYS ARE PRESSED AN AUTOMATIC OUTPUT OF THE #3 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. NUMERICALLY: WHEN THE #1K EY IS PRESSED, 13 WILL BE DISPLAYED, ALPHABETICALLY: WHEN THE "ABC" KEY IS PRESSED, AG WILL BE DISPLAYED INTERFERING WITH CARE AREA AND MDL DRUG SEARCHING OPPORTUNITIES). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS THAT A SPECTRUM PUMP'S #3 KEY WAS STUCK. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289423 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1