BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2070036 · Received April 26, 2011

    Report

    Report Number
    6000001-2011-03194
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT 2 OF 2. THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT TWO INTERMATE UNITS IN WHICH BOTH UNITS WERE BROKEN. BOTH UNITS WERE FILLED WITH 90 MILLIGRAMS IN 250 MILLILITERS OF 0.9% SODIUM CHLORIDE INJECTION. THE ADMIXTURE WAS PREPARED AND SHIPPED ACCORDING TO LOCAL PROCEDURES. THERE WERE NO LEAKS OBSERVED DURING THE PROCESSING AND PACKAGING. CUSTOMER FOLLOW UP ON (B)(6) 2011 INDICATED THAT BOTH UNITS WERE LEAKING WITHIN THE OVERPOUCH; BOTH UNITS WERE DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M063

    Patients

    Seq Age Sex Outcome Treatment
    1