BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1840308 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03399
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. THE REPORTED CONDITION OF A BROKEN FILL PORT CAP WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE OPENED DURING MANUFACTURING OF THIS DEVICE. TREND REVIEW DETERMINED THAT SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR SV 200 DEVICE HAS A CRACKED FILLING PORT CAP BEFORE USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 07K080

    Patients

    Seq Age Sex Outcome Treatment
    1