BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1900657 · Received November 16, 2010

    Report

    Report Number
    6000001-2010-04915
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    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). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAKING" WAS CONFIRMED. EXAMINATION OF THE DEVICE REVEALED THE LEAK WAS CAUSED BY CRACKS ON THE LUER. NO OTHER CAUSE OF LEAK WAS FOUND ON THE DEVICE. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV100 DEVICE WAS OBSERVED LEAKING AT AN UNKNOWN LOCATION OF THE DEVICE BEFORE USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 250ML OF PAMIDRONATE (CONCENTRATION 90 MG IN 250 ML OF 0.9% SODIUM CHLORIDE). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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 - IRVINE 10G038

    Patients

    Seq Age Sex Outcome Treatment
    1