BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3872855 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18926
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    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 TRANSFER SET WAS RETURNED, AND THE EVALUATION WAS COMPLETED. VISUAL INSPECTION AND MICROSCOPIC INSPECTION WERE PERFORMED AND REVEALED NO ABNORMALITIES. UNDERWATER LEAK TESTING, CLEAR PASSAGE TESTING AND CLAMP FUNCTIONAL TESTING WERE PERFORMED WITH NO ISSUES NOTED. INTEGRITY OF SEAL SURFACE TESTING WAS ALSO PERFORMED WITH NO ISSUES NOTED. THE INTERNAL DIAMETER OF THE PATIENT ADAPTER WAS MEASURED, AND IT WAS WITHIN SPECIFICATION LIMITATIONS. THE REPORTED CONNECTION ISSUE WAS UNABLE TO BE VERIFIED DURING SAMPLE ANALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONNECTOR OF A UV FLASH TRANSFER SET WOULD NOT CONNECT SECURELY TO A TITANIUM ADAPTER. THIS OCCURRED DURING PATIENT USE. THE REPORTER STATED THAT THE PATIENT CONNECTOR WOULD ¿RUN IDLE AND NOT STOP AGAINST¿ THE ADAPTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349799 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER