BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3222884 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18126
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CAUSE WAS DETERMINED TO BE A MACHINE FOUND IN THE MANUFACTURING PROCESS. UPDATES WERE MADE TO THE MACHINE IN ORDER TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND WAS LEAK TESTED. A LEAK AT THE PORT TUBE SEAL WAS IDENTIFIED. THE CAUSE OF THE REPORTED MALFUNCTION WAS A MANUFACTURING ISSUE. APPROPRIATE CORRECTIVE ACTIONS HAVE BEEN TAKEN TO REMEDIATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EVA BAG LEAKED TOTAL PARENTERAL NUTRITION SOLUTION. THE LIQUID WAS OBSERVED TO LEAK FROM THE BOTTOM OF THE BAG "IN THE SITE OF THE CONNECTORS." THIS MALFUNCTION WAS REPORTED TO HAVE BEEN OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323070 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SE13AC1

    Patients

    Seq Age Sex Outcome Treatment
    1