BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891544 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05279
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A SYSTEM ERROR 322 ALARM WAS FOUND IN THE HISTORY LOG OF A PUMP THAT WAS EVALUATED DURING A SITE VISIT. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68903 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1