BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2231945 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22208
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 9, 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). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION OF THE BLADDER RUPTURE ISSUE IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE HAD A RESERVOIR RUPTURE DURING PATIENT USE. THE DEVICE WAS FILLED WITH A 150-ML SOLUTION OF 70 MG FABRAZYME IN SALINE. THIS CONDITION INTERRUPTED THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11B078

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| FABRAZYME