BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3961610 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24474
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 3, 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). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED. A MICROSCOPIC INSPECTION FOUND NO ISSUES WITH THE DEVICE. LEAK TESTING, CLAMP FUNCTION TEST, AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. SAMPLE ANALYSIS DID NOT VERIFY THE EVENT AND THE SAMPLE ANALYSIS DETERMINED THE PRODUCT MET PRODUCT SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRANSFER SET WAS RETURNED AND A DEVICE ANALYSIS IS ANTICIPATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UV FLASH TRANSFER SET DISCONNECTED FROM THE TITANIUM ADAPTER DURING USE. THE TRANSFER SET WAS IN USE FOR 102 DAYS PRIOR TO THE DISCONNECTION. 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
    439413 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER