BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3830313 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16785
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 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 ACTUAL DEVICE WAS NOT AVAILABLE HOWEVER THE COMPANION SAMPLES ARE REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A TRANSFER SET FROM THE SAME LOT WAS RETURNED UNUSED AND IN AN OPENED POUCH THE EVALUATION WAS COMPLETED ON THE COMPANION SAMPLE. THE SAMPLE WAS VISUALLY INSPECTED WITH THE NAKED EYE, AS WELL AS WITH A MICROSCOPE. VISUAL INSPECTIONS IDENTIFIED DAMAGE TO THE PATIENT CONNECTOR. THE DAMAGE WAS LIMITED TO THE OUTSIDE OF THE CONNECTOR. LEAK, CLEAR PASSAGE, AND CLAMP FUNCTIONAL TESTING ALL PASSED. THE INTEGRITY OF THE SEAL SURFACE TEST PASSED. THE INNER DIAMETER OF THE PATIENT CONNECTOR WAS WITHIN SPECIFICATION LIMITS. ALTHOUGH DAMAGE WAS NOTED ON THE PATIENT CONNECTOR, THE TRANSFER SET WAS ABLE TO PASS ALL FUNCTIONAL TESTING. THE REPORTED CONNECTION ISSUE WAS UNABLE TO BE VERIFIED NOR DUPLICATED DURING SAMPLE ANALYSIS. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS PERFORMED AND NO ISSUES WERE NOTED DURING THE MANUFACTURE OF THE LOT. 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 DID NOT CONNECT WELL TO A TITANIUM ADAPTER. THE REPORTER STATED THIS OCCURRED WHEN THE CUSTOMER CONNECTED THE TRANSFER SET FOR THE FIRST TIME. 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
    307464 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13I16036

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER