BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 1871383 · Received October 15, 2010

    Report

    Report Number
    6000001-2010-04067
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 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). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. A SMALL AMOUNT OF SOLUTION WAS NOTED IN THE BAG THAT CONTAINED THE SAMPLE. THE BLUE WINGED CAP WAS VISUALLY NOTED TO BE ADEQUATELY FASTENED TO THE LUER BODY. DURING THE LEAK TEST, THE SAMPLE WAS ALLOWED TO COMPLETELY PRIME THEN THE BLUE WINGED CAP WAS SECURELY FASTENED TO THE LUER BODY. AFTER 3 DAYS OF MONITORING PERIOD, NO SIGNS OF LEAK WERE OBSERVED ON THE SAMPLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS A SINGLE USE DEVICE AND HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE 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 ANY FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) HALF DAY INFUSOR DEVICE WAS OBSERVED LEAKING. ACCORDING TO THE REPORT, THE DEVICE IS FILLED WITH DEFERRIOXAMINE (CONCENTRATION 2.5G IN 50ML OF WATER FOR IRRIGATION). THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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 10G001

    Patients

    Seq Age Sex Outcome Treatment
    1