BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 5305862 · Received September 9, 2004

    Report

    Report Number
    6000001-2004-01403
    Event Type
    Malfunction
    Date Received
    September 9, 2004
    Date of Event
    September 1, 2004
    Report Date
    September 1, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE LED.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION OF FAIL CODE 538 WAS CONFIRMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FAIL CODE 538. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION, PATIENT DEMOGRAPHICS, MEDICATION INVOLVED, OR PUMP PROGRAMMING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT REGARDING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP FRN BAXTER HEALTHCARE PTE LED. COLLEAGUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK