BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR TWO DAY 2ML/HR 12 PK

    MDR report key: 1913101 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05390
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 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). THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION OF A STOPPAGE OF DELIVERY. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INFUSOR TWO DAY DEVICE HAD STOPPED DELIVERING DURING PATIENT USE AT THE PATIENT'S HOME. IN ADDITION, THE BAXTER SALES REPRESENTATIVE VERIFIED THE DEVICE WAS NOT FLOWING WHEN HE RECEIVED THE SAMPLE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR TWO DAY 2ML/HR 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10D024

    Patients

    Seq Age Sex Outcome Treatment
    1