BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2171528 · Received July 21, 2011

    Report

    Report Number
    6000001-2011-13305
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAXTER HEALTHCARE ? IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE IS NOT AVAILABLE TO BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED COMPLAINT INCIDENT FOR OVERINFUSION CANNOT BE DETERMINED SINCE THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSION PUMP IN WHICH THE INFUSION TIME WAS COMPLETED IN 24 HOURS INSTEAD OF THE EXPECTED 46 HOURS. THERE WAS PATIENT INVOLVEMENT. 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 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE ? IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY