BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLE DAY 2ML/HR 12PK

    MDR report key: 1823162 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02938
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED AT BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD RUPTURED AFTER FILLING. AFTER A COUPLE OF MINUTES OF FILLING, THE RESERVOIR RUPTURED. THE DEVICE WAS FILLED WITH BELO AND NORMAL SALINE 48 MILLILITERS. THERE IS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATE WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLE DAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1