BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3101756 · Received April 30, 2013

    Report

    Report Number
    1314492-2013-00467
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM OF "INTERMITTENTLY TURNS OFF" COULD NOT BE REPRODUCED NOR BE QUALIFIED DUE TO THE ABSENCE OF "IMPROPER SHUTDOWN" ENTRIES IN THE HISTORY LOG. "IMPROPER SHUTDOWN" IS ALWAYS THE PRODUCT OF A PUMP SHUTTING OFF BY ITSELF OTHER THAN FOLLOWING A DEAD BATTERY ALERT. BAXTER'S DEVICE EVALUATION FOUND A SYSTEM ERROR 322 ENTRY IN THE HISTORY LOG DURING THE INFUSION SEGMENT. THE HISTORY LOG SHOWS THAT AFTER THE SYSTEM ERROR 322 THE UNIT WAS POWERED OFF BY A USER AS INDICATED IN THE LOG AS "PUMP OFF". UNIT EXPERIENCED SYSTEM ERROR 322 DURING TESTING CAUSED BY A FAILED UPPER AUXILIARY FLEX. IT IS LIKELY THE CUSTOMER MISINTERPRETED THE SYSTEM ERROR 322 AS THE PUMP TURNING OFF. THE UPPER AUXILIARY FLEX WAS REPLACED. THE CUSTOMER WILL BE ISSUED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP INTERMITTENTLY TURNS OFF AND THAT THIS OCCURRED DURING AN INFUSION IN CCU. THE THERAPY WAS INTERRUPTED. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187707 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1