BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1963148 · Received January 18, 2011

    Report

    Report Number
    6000001-2011-00328
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OVERINFUSION WAS NOT CONFIRMED OR DUPLICATED, THEREFORE AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BATCH REVIEW WAS CONDUCTED WITH NO ABNORMALITY OBSERVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(6) OF AN INFUSOR THAT OVERINFUSED DURING PATIENT USE AT THE PATIENT HOME. THE ACTUAL FLOW RATE WAS 225ML/42HR. THE TOTAL FILL VOLUME WAS 225ML 5-FLUOROURACIL 66ML AND SALINE 159ML. THE TEMPERATURE WAS 33?. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. 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 10K034

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE