BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1873238 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04204
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 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).ADDITIONAL NARRATIVE: PER THE REPORTER THE DEVICE HAS BEEN THROWN OUT BY THE CUSTOMER; THEREFORE, THE REPORTED CONDITION OF "LEAKING INTERMATE" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, 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 SV50 DEVICE WAS OBSERVED LEAKING BEFORE USE. THE DEVICE WAS FILLED WITH PAMIDRONATE (90MG IN 250ML NACL 0.9%). THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 50, 24 PACK, 50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B075

    Patients

    Seq Age Sex Outcome Treatment
    1