BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1761332 · Received July 19, 2010

    Report

    Report Number
    6000001-2010-01760
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION:A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT SEND THE DEVICE TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF THE DEVICE DELIVERING FASTER THAN INTENDED COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED OUTSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN HAD ADVANCED THE 2.25X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS), BUT NOTED THAT THE VESSEL REQUIRED ADDITIONAL PREDILATION. THE SDS WAS REMOVED SO THE LESION COULD BE PREDILATED. WHEN THE PHYSICIAN RE-ENTERED WITH THE SDS, HE NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON, BUT THAT IT HAD DISLODGED AND WAS FOUND ON THE PATIENT'S TABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 10 DEVICE DELIVERED IN A FASTER THAN EXPECTED TIME DURING A PATIENT INFUSION. THE PUMP FULLY INFUSED A SOLUTION OF 8 GRAMS OF FLUCLOXACILLIN AND 240ML OF NORMAL SALINE 2-3 HOURS EARLIER THAN INTENDED. 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 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C057

    Patients

    Seq Age Sex Outcome Treatment
    1