BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4688159 · Received November 28, 2014

    Report

    Report Number
    1314492-2014-73063
    Event Type
    Malfunction
    Date Received
    November 28, 2014
    Date of Event
    October 1, 2014
    Report Date
    November 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K42121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: 220337. THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE AIR-IN-LINE ALARMS WERE CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS REC'D A F/U WILL BE SENT. THE PROCESSOR PRINTED CIRCUIT BOARD WAS REPLACED.

    Description of Event or Problem · 1

    DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 71 OCCURRENCES OF 'AIR-IN-LINE' ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK SINCE THESE ITEMS WERE FOUND DURING EVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772081 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1