BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR,LV 10 ML/H 12 PACK

    MDR report key: 1844265 · Received September 24, 2010

    Report

    Report Number
    6000001-2010-03511
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    May 11, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED BY BAXTER. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES 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). THE REPORTED CONDITION WAS CONFIRMED. A BATCH REVIEW HAS BEEN PERFORMED. ALL OF THE RELEASE CRITERIA HAVE BEEN MET FOR THE PRODUCTION OF THIS LOT. THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION IDC-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD LIQUID LEAK INTO THE BOTTLE FROM THE RESERVOIR. THE EVENT OCCURRED DURING FILLING. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR,LV 10 ML/H 12 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 08A070

    Patients

    Seq Age Sex Outcome Treatment
    1