BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2152070 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08734
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    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 DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS REPORT WAS CONFIRMED BY A PLANT EVALUATION AS VISIBLE WHITE RESIDUE INTERNAL TO THE TRANSFER SET. THE WHITE RESIDUE WAS OBSERVED AFTER USE, WHICH LAB ANALYSIS BY THE BAXTER ANALYTICAL LABORATORY WAS FOUND TO BE SODIUM CHLORIDE, NORMAL TABLE SALT. THIS SUBSTANCE IS NOT PRESENT IN PRODUCT MANUFACTURING PROCESSES. A BATCH REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT KNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT WHITE PARTICULATE MATTER (PM) WAS FOUND IN THE TUBING DURING USE. THE PATIENT THOUGHT THAT THE WHITE PM MUST BE SOME OF THE ELEMENTS IN THE SOLUTION WHICH WAS CRYSTALLIZED. THE PATIENT SAID THE SOLUTION HAD BEEN CONTAINED IN THE TUBING FOR A LONG TIME DURING DAY TIME AND GOT CRYSTALLIZED IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1