BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2100212 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04428
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 5, 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). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. 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 TIER II (B)(4).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE INTERMATE LV250 DEVICE RUPTURED AT THE LEVEL OF THE BLADDER. REPORTEDLY, THE BLADDER RUPTURED 45 MINUTES AFTER THE INFUSION STARTED. THE DEVICE WAS FILLED WITH FORTUM 6G. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES 1 OF 2, AS THE FACILITY REPORTED 2 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10F050

    Patients

    Seq Age Sex Outcome Treatment
    1 FORTUM