BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1840455 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03401
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT SEND THE DEVICE TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR RUPTURED RESERVOIRS IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). A BATCH REVIEW WAS PERFORMED REVEALING AN EXCEPTION REPORT WAS DOCUMENTED FOR THIS LOT. HOWEVER, THE ISSUE ASSOCIATED WITH THIS EXCEPTION REPORT IS NOT CURRENTLY SEEN AS CONTRIBUTING TO THE CUSTOMER REPORTED AND CONFIRMED PROBLEM. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR LV 10 DEVICE RUPTURED BEFORE USE. THE DEVICE WAS FILLED WITH A SOLUTION OF 8000MG OF FLUCLOXACILLIN IN 0.9% SODIUM CHLORIDE AT THE TIME OF THE RUPTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G030

    Patients

    Seq Age Sex Outcome Treatment
    1