BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1232097 · Received November 7, 2008

    Report

    Report Number
    6000001-2008-00729
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED IN BAXTER AND IS BEING EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH AN ELECTRICAL FAULT 32 CODE. THIS EVENT OCCURRED DURING PATIENT INFUSION, WHICH MAY HAVE CAUSED THE INFUSION TO STOP. NO PATIENT INJURY OR PATIENT INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION 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