BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1984381 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00862
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 26, 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). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "OVER INFUSION" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD ALSO NOT BE PERFORMED AS THE LOT NUMBER OF THIS SAMPLE WAS NOT REPORTED BY THE CUSTOMER. 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 (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 LV5 DEVICE HAD OVERINFUSED DURING PATIENT USE AT THE PATIENT'S HOME. THE EXPECTED FLOW RATE IS UNKNOWN, BUT THE ACTUAL FLOW RATE WAS 215ML IN 38 HOURS. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND 5% GLUCOSE AND CONNECTED VIA A HUBER NEEDLE. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 5-FLUOROURACIL| HUBER NEEDLE| (B)(4) GLUCOSE