BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1820247 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02851
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - DEERFIELD
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE TO BAXTER FOR EVALUATION. A BATCH REVIEW HAS BEEN PERFORMED. A NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT, BUT THE ISSUE IN THE NONCONFORMANCE REPORT IS NOT FORESEEABLE TO CONTRIBUTE TO THE REPORTED CONDITION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITONAL INFORMATION BEDCOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD LEAKED INTO THE OVERPOUCH. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE EVENT OCCURRED DURING STORAGE. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - DEERFIELD 10E078

    Patients

    Seq Age Sex Outcome Treatment
    1