BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2922745 · Received December 28, 2012

    Report

    Report Number
    1314492-2012-00557
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THE PUMP TO TURN ON WHEN THE CASE IS PRESSED. FURTHER EVAL DETERMINED THAT THIS WAS DUE TO A FAILED UPPER HOOK SWITCH. THE DATE OF EVEN IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP TURNS ON W/O USER INPUT. THE CUSTOMER ALSO STATED THAT THIS WAS FOUND WHILE THE DEVICE WAS IN AN AMBULANCE, AND 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