BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2911158 · Received December 7, 2012

    Report

    Report Number
    1314492-2012-00496
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. IT WAS CONFIRMED THAT THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVALUATION IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO A FAILED BACK FLEX. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED. THE SIGMA DEVICE EVAL ALSO FOUND THE PUMP WAS UNABLE TO CHARGE A BATTERY OR OPERATE ON AC POWER DUE TO A FAILED BACK FLEX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT HAVE AUDIO FUNCTION. ADDITIONALLY, IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE. THE CUSTOMER ALSO STATED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1