BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2, 12 PACK

    MDR report key: 2032143 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02277
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 2011
    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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "BACKFLOW" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INFUSOR SV 2 DEVICE WAS OBSERVED BACKFLOWING AT THE FILL PORT CAP DURING FILLING. THIS COULD LEAD TO A BREACH IN THE STERILE FLUID PATHWAY. THE DEVICE WAS BEING FILLED WITH 5-FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL