BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6464602R PCA II PUMP REFUBISHED

    MDR report key: 1911202 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05340
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - ANDOVER
    Product Code
    FRN
    PMA / PMN Number
    K902613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION NOT CONFIRMED AND NOT DUPLICATED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED PRIOR TO THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A PCA II IN WHICH THE DEVICE DOES NOT ADMINISTER MEDICATION. THERE WAS A NON DELIVERY THAT OCCURRED DURING PROGRAMMING/SET-UP. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6464602R PCA II PUMP REFUBISHED PUMP, INFUSION FRN BAXTER HEALTHCARE - ANDOVER

    Patients

    Seq Age Sex Outcome Treatment
    1