BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1984352 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00857
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND CONFIRMED THE REPORTED CONDITION OF A RESERVOIR RUPTURE. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INTERMATE LV 250 DEVICE RUPTURED DURING PATIENT USE. THE DEVICE HAD BEEN DELIVERING 160 MILLIGRAMS GENTAMYCINE TO THE PATIENT FOR 45 MINUTES WHEN THE RESERVOIR RUPTURED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10F050

    Patients

    Seq Age Sex Outcome Treatment
    1 GENTAMYCINE