BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1891452 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05276
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    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). EVALUATION SUMMARY: THE SET WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE OBSERVED. THE SET WAS PRESSURE TESTED WITH NO LEAKAGE NOTED, AND CLEAR PASSAGE OBSERVED. THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED IN THE LAB. THE RESULTS OF A SAMPLE EVALUATION REVEALED NO MANUFACTURING ABNORMALITIES OR LEAKS. THE LOT NUMBER WAS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THIS IS AN INTERNATIONAL CODE FOR DISTRIBUTION OUTSIDE OF THE U.S. BUT IS BEING REPORTED AS IT IS THE SAME AS OR SIMILAR TO A CODE DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED FROM BAXTER (B)(4) OF A NURSE WHO REPORTED THE SPIKE SEPARATED FROM THE SOLUTION BAG WHEN THE CUSTOMER TRIED TO SET THE TRANSFER SET TO THE CLEAN FLASH AFTER FILLING. THE ACTUAL SAMPLE IS AVAILABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1