BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3854328 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18241
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRANSFER SET WAS RETURNED, AND THE EVALUATION WAS COMPLETED. VISUAL INSPECTION (MICROSCOPIC AND NAKED EYE) DISCOVERED DAMAGE TO THE PATIENT ADAPTER. UNDERWATER LEAK, CLEAR PASSAGE AND CLAMP FUNCTIONAL TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE INTERNAL DIAMETER OF THE PATIENT ADAPTER WAS MEASURED, AND IT WAS WITHIN SPECIFICATION LIMITATIONS. ALTHOUGH DAMAGE WAS FOUND ON THE PATIENT ADAPTER, THE TRANSFER SET WAS ABLE TO PASS ALL SUBSEQUENT TESTING AND MEASURED WITHIN SPECIFICATION LIMITS. THE REPORTED CONNECTION ISSUE WAS UNABLE TO BE VERIFIED. 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 SEPARATED FROM A TITANIUM ADAPTER ¿VERY EASILY¿ WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THIS OCCURRED DURING PATIENT USE. 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
    332909 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1