BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1243118 · Received November 21, 2008

    Report

    Report Number
    6000001-2008-00780
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED IN BAXTER, BUT HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AN EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH AN UNINTENDED SHUTDOWN. THIS EVENT OCCURRED AT AN UNK TIME. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP 80FRN MEA BAXTER HEALTHCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1