BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3250168 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19868
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE SAMPLE HAS BEEN RECEIVED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING ON THE RETURNED UNIT SHOWED NO EVIDENCE OF THE REPORTED RUPTURE ON THE BLADDER. THE BLADDER WAS FOUND TO BE IN ITS NORMAL CONDITION. THE REPORTED CONDITION WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LARGE VOLUME INTERMATE'S BALLOON RUPTURED. THIS MALFUNCTION WAS OBSERVED UPON RECEIPT; THE CUSTOMER REPORTED THAT THEY NOTICED THE BOX WAS WET. THERE WERE APPROXIMATELY 10 ML OF SOLUTION REMAINING INSIDE OF THE INTERMATE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351620 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13C091

    Patients

    Seq Age Sex Outcome Treatment
    1