BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1875050 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04270
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - DEERFIELD
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "LEAKING INTERMATE" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV100 DEVICE WAS OBSERVED LEAKING AT THE PATIENT'S HOME. THE DEVICE WAS FILLED WITH PAMIDRONATE (90MG IN 250ML SODIUM CHLORIDE 0.9%). THIS WAS DISCOVERED BEFORE USE BY THE CUSTOMER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE FILL PORT AND BLUE WINGED CAPS WERE CHECKED AND TIGHTENED PRIOR TO PACKAGING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - DEERFIELD 10G036

    Patients

    Seq Age Sex Outcome Treatment
    1