BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 2061139 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02932
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS REPORT 1 OF 2.

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK CONDITION NOT CONFIRMED. VISUAL EXAMINATION REVEALED NO SIGNS OF LEAK OR MOISTURE WERE NOTED AT THE BLUE WINGED LUER CAP, OR ANYWHERE ON THE UNIT. A LEAK WAS PERFORMED ON THE UNITS BY REFILLING THE BLADDER WITH GREEN WATER THEN MONITORED FOR 24 HOURS. NO SIGNS OF DEFECT COULD BE FOUND ANYWHERE ON THE UNIT. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV 100 EXPERIENCED A LEAK AT THE BLUE WINGED LUER CAP. THIS DEVICE WAS FILLED WITH PAMIDRONATE 90MG/250ML AND SODIUM CHLORIDE. THE LEAK WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND, THEREFORE, NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THE REPORTED CONDITION OF A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION, ELASTOMERIC FRN BAXTER HEALTHCARE - IRVINE 10N008

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE| PAMIDRONATE 90MG/250ML