BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3831101 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16911
    Event Type
    Malfunction
    Date Received
    May 23, 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
    PHYSICIAN

    Narratives

    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. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS PERFORMED, AND IT REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE LOT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GAP WAS OBSERVED BETWEEN THE PATIENT CONNECTOR OF THE UV FLASH TRANSFER SETS AND THE TITANIUM ADAPTOR. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308927 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13J10038

    Patients

    Seq Age Sex Outcome Treatment
    1