BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE, SV 100, 24 PACK

    MDR report key: 1941453 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06330
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    September 20, 2010
    Report Date
    December 8, 2010
    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). ADDITIONAL INFORMATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INTERMATE SV 200 DEVICE RUPTURED DURING PATIENT USE. THE DEVICE WAS INFUSING THE PATIENT WITH IRON IN 100 MILLILITERS NACL WHEN THE RESERVOIR RUPTURED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE, SV 100, 24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10C072

    Patients

    Seq Age Sex Outcome Treatment
    1