BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3180649 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16025
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES. THE INTEGRITY OF THE SEAL SURFACE WAS TESTED AND NO LEAKS WERE NOTED. THE INSIDE DIAMETER OF THE PATIENT CONNECTOR ON THE DEVICE WAS MEASURED AND FOUND TO BE BELOW NOMINAL. IMPROVEMENTS WERE MADE TO THE MOLD AND THE MOLDING DEPARTMENT PROCEDURES TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A CONNECTION ISSUE WITH A UV FLASH TRANSFER SET THAT WAS NOT CONNECTED WELL TO THE LOCKING TITANIUM ADAPTER WHILE THE PATIENT WAS DOING THERAPY FOR PERITONEAL DIALYSIS. THE CAUSE OF THE CONNECTION ISSUE WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281588 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING TITANIUM ADAPTER