BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1800016 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02561
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A SINGLE DAY INFUSOR DEVICE WAS LEAKING AFTER FILLING. THE DEVICE HAD BEEN FILLED WITH DESFERRIOXAMINE WHEN THE LEAK WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLEDAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10B029

    Patients

    Seq Age Sex Outcome Treatment
    1