BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUME SET FOR UV FLASH

    MDR report key: 1813640 · Received August 25, 2010

    Report

    Report Number
    1423500-2010-02859
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) 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 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF THE SUPPLY LINE SEPARATING FROM THE SUPPLY BAG WAS NOT CONFIRMED IN THE LAB. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CONNECTION BETWEEN THE 5L BAG AND ONE OF THE BAG LINES WAS SEPARATED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 MONTHS (5.67 MONTHS) DUE TO ENDOCARDITIS FROM CANDIDA SP. THE DEVICE WAS REPLACED BY THE SAME MODEL, SMALLER SIZE DEVICE. THERE WAS NO INDICATION AS TO THE SOURCE OF THE INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUME SET FOR UV FLASH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SINGAPORE S10E04041

    Patients

    Seq Age Sex Outcome Treatment
    1