BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, 24 PACK,50126

    MDR report key: 1904855 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05042
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 CAPA# IDC-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "RESERVOIR RUPTURED" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) INTERMATE LV250 DEVICE HAD RUPTURED DURING PATIENT USE. THE DEVICE WAS FILLED WITH AN UNKNOWN ANTIBIOTIC AND THEN CONNECTED TO THE PATIENT. NEAR THE END OF INFUSION, THE RESERVOIR BURST. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10H028

    Patients

    Seq Age Sex Outcome Treatment
    1