BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIRATE INFUSOR LV 2,4,6 12PACK FOR JAPAN ONLY

    MDR report key: 1973454 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00531
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 (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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A RUPTURED RESERVOIR. THE DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH IDC-CAPA-(B)(4). 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

    DURING THE EVALUATION OF THIS MULTIRATE INFUSOR LV SAMPLE PERFORMED BY BAXTER, IT WAS OBSERVED THAT THE RESERVOIR WAS RUPTURED. THIS WAS OBSERVED DURING SERVICE AND NOT REPORTED BY THE CUSTOMER. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIRATE INFUSOR LV 2,4,6 12PACK FOR JAPAN ONLY PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C066

    Patients

    Seq Age Sex Outcome Treatment
    1