BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3831714 · Received May 26, 2014

    Report

    Report Number
    1416980-2014-16980
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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 RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE RETURNED SAMPLE AND FOUND UNRELATED ISSUES. LEAK TESTING, CLAMP FUNCTION TESTING, AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THE ACTUAL SAMPLE DID NOT MEET SPECIFICATIONS BASED ON ADDITIONAL DEFECTS IDENTIFIED; HOWEVER THE REPORTED COMPLAINT OF LEAK WAS NOT VERIFIED THROUGH EVALUATION. 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 A UV FLASH SOLUTION TRANSFER SET LEAKED DURING PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309987 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1