BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1082056 · Received July 23, 2008

    Report

    Report Number
    6000001-2008-00429
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT BAXTER EVAL. SHOULD THE DEVICE BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF EVAL.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO LARGO CUSTOMER SERVICE A PUMP WITH A ERROR CODE 30, WHICH CAUSED THE PUMP TO BECOME INOPERABLE DURING PT USE. 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