BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4483200 · Received July 23, 2014

    Report

    Report Number
    1314492-2014-45888
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT 180171. THE DOWNSTREAM OCCLUSION ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS RECEIVED, A F/U WILL BE SENT. THE PROCESSOR PRINTED CIRCUIT BOARD WAS REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE SYSTEM ERROR 322 ALARMS.

    Description of Event or Problem · 1

    DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 1 OCCURRENCE OF "SYSTEM ERROR 322" ALARM WAS IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK SINCE THIS ITEM WAS FOUND DURING EVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432883 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1