BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3191169 · Received June 14, 2013

    Report

    Report Number
    1314492-2013-00786
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 16, 2013
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER REC'D AND EVALUATED THE DEVICE IN QUESTION. THE EVALUATION FOUND THAT KEYS #8 AND #9 WERE INOPERABLE. WHEN ANY KEY IS PRESSED THERE IS AN AUTOMATIC OUTPUT OF THE #9 KEY. THIS IS CAUSED BY A FAILED KEYPAD. THE KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAS A KEYPAD THAT IS NOT RESPONDING. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272343 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1