BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2911180 · Received December 7, 2012

    Report

    Report Number
    1314492-2012-00494
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 8, 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 OBSERVED THAT APPROXIMATELY 1 SECOND AFTER THE PUMP IS POWERED ON, THE DEVICE WILL LOSE POWER AND TURN OFF WITHOUT USER INPUT. FURTHER EVAL FOUND THE POWER OFF WITHOUT USER INPUT WAS DUE TO A FAILED PROCESSOR PRINTED CIRCUIT BOARD. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP TURNS OFF WITHOUT USER INPUT. THE CUSTOMER STATED THAT THE PUMP WILL NOT REMAIN POWERED ON.

    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