BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1973441 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00530
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING FLUID IN THE RESERVOIR. TO VERIFY THE REPORTED CONDITION, THE FILL-PORT CAP WAS REMOVED. UPON REMOVAL, A BACK-FLOW (LEAK) WAS OBSERVED AT THE FILL-PORT. NO OTHER OBSERVATION WAS NOTED. THE SAMPLE WAS SUBSEQUENTLY DISASSEMBLED FOR EXAMINATION. AS A RESULT, ACRYLIC RESIN (1.1 MM IN SIZE) WAS FOUND BETWEEN THE CHECK-BAND AND STRESS-MEMBER, WHICH EVIDENTLY HAD CAUSED THE BACK-FLOW CONDITION. NO OTHER ROOT CAUSE WAS FOUND. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT ONE (1) INFUSOR LV5 DEVICE WAS OBSERVED WITH A BACKFLOW/LEAK AT THE LOCATION OF THE FILL PORT DURING FILLING. ACCORDING TO THE REPORT THE DEVICE WAS BEING FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09F046

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE| 5-FLUOROURACIL