BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2872209 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07050
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    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 ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. RECEIVED USED SET WITH CAP ON UV SPIKE CONNECTOR. VISUAL INSPECTION PERFORMED WITH THE FOLLOWING ISSUES NOTED: CUT IN TUBING. LEAK TESTING PERFORMED WITH THE FOLLOWING ISSUES NOTED: CUT IN SILICONE TUBING. CLEAR PASSAGE TEST PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST PERFORMED WITH NO ISSUES NOTED. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW UP WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT THERE WAS LEAKAGE FROM THE SILICONE TUBING OF THE TRANSFER SET FOUND DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT.

    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 HOME CHOICE