BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR, LV 5 ML/H,12 PACK

    MDR report key: 1885324 · Received October 28, 2010

    Report

    Report Number
    6000001-2010-04575
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION 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 OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIRS OF 2 INFUSOR LV 5 DEVICES RUPTURED DURING FILLING. THIS IS REPORT 2 OF 2. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR, LV 5 ML/H,12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09J028

    Patients

    Seq Age Sex Outcome Treatment
    1