BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE XLV 250, 12 PACK

    MDR report key: 1911221 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05343
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K943664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    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 WAS CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. ADDITIONAL: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH IDC-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INTERMATE IN WHICH THE RESERVOIR RUPTURED DURING PATIENT USE. THE EVENT OCCURRED CLOSE TO THE END OF THE INFUSION. THE PATIENT DID NOT RECEIVE THE FULL STANDING THERAPY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE DEVICE HAD NOT BEEN COOLED PRIOR TO THE PATIENT APPLICATION, AND THE PATIENT WAS NOT RECEIVING ANY OTHER DRUGS THROUGH THE PORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE XLV 250, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F077

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR