BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1082057 · Received July 23, 2008

    Report

    Report Number
    6000001-2008-00430
    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
    FRN
    PMA / PMN Number
    K956385
    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 FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO LARGO CUSTOMER SERVICE A PUMP WITH AN ERROR CODE 32, WHICH CAUSED THE PUMP TO BECOME INOPERABLE DURING PT USE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1