BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 1781528 · Received August 3, 2010

    Report

    Report Number
    6000001-2010-02210
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF LEAK WAS CONFIRMED. TWO UNITS WERE RECEIVED. THE FIRST UNIT CONTAINED APPROXIMATELY 55 ML OF SOLUTION IN THE RESERVOIR, AND WITHOUT ANY SIGNS OR EVIDENCE OF LEAKAGE. THE SECOND UNIT CONTAINED APPROXIMATELY 10 ML OF SOLUTION IN THE RESERVOIR, AND ABOUT 40 ML IN THE HOUSING DUE TO LEAKAGE. NO OTHER OBSERVATION WAS NOTED ON THE UNITS UPON RECEIPT. A LEAK TEST WAS PERFORMED ON THE UNITS BY REFILLING THEM WITH GREEN COLOR WATER. AS A RESULT, LEAKAGE WAS DETECTED ON THE RESERVOIR OF THE FIRST UNIT DUE TO A PIN-HOLE. NO EVIDENCE OF LEAKAGE WAS FOUND FROM THE SECOND UNIT DURING THE LEAK TEST. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 2 UNITS WERE REJECTED AT THEIR PACKING STAGE DUE TO THE DEVICES LEAKING. BOTH UNITS HAVE BEEN FILLED WITH DESFERRIOXAMINE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALF DAY INFUSOR, 5ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C076

    Patients

    Seq Age Sex Outcome Treatment
    1