BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2110853 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06959
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF LEAK DUE TO CUT ON THE TUBING WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT CONFIRMED THAT THE DELIVERY TUBING WAS HALF-WAY CUT, WITH A SMOOTH SURFACE ON THE CUT (RATHER THAN A JAGGED SURFACE). THE ROOT CAUSE WAS OPERATOR ERROR (B)(4). NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE FOLFUSOR SV 4ML DEVICE LEAKED. AS THE INFUSOR WAS BEING FILLED, THE INFUSION TUBE LEAKED. IT SEEMS AS IF THE TUBE WAS CUT/RIPPED. ONE UNIT AFFECTED / SAMPLES AVAILABLE. THE REPORTED COMPLAINT TOOK PLACE BEFORE PATIENT CONNECTION, NO PATIENT INVOLVEMENT. THE DEVICE WAS FILLED WITH SALINE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10N066

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE