BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE, SV 100, 24 PACK

    MDR report key: 1963138 · Received January 18, 2011

    Report

    Report Number
    6000001-2011-00329
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED DURING FILLING. THE DEVICE WAS FILLED WITH NATRIUM CHLORIDE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL: A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SAMPLE RECEIPT DATE HAS BEEN PROVIDED. DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS A FAULTY SLIDE CLAMP.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INTERMATE IN WHICH THE DEVICE HAD BECOME LOOSE NEAR THE WING. THE TUBING THAT WAS CONNECTED TO THE DEVICE WAS SV 100 MILLILITERS/HOUR, 105 MILLILITERS. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE, SV 100, 24 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J010

    Patients

    Seq Age Sex Outcome Treatment
    1 SV 100 MILLILITERS/HOUR, 105 MILLITERS| NATRIUMCHLORIDE