BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE MULTIRATE INFUSOR LV2,3,512 PACK

    MDR report key: 2002211 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01390
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    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 BROKEN DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE 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

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A MULTI-RATE INFUSOR DEVICE BROKE DURING FILLING. THE DEVICE WAS BEING FILLED WITH ANALGESIC SOLUTION WHEN THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE MULTIRATE INFUSOR LV2,3,512 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G028

    Patients

    Seq Age Sex Outcome Treatment
    1 ANALGESIC SOLUTION