BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1984297 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01755
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    October 16, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH NO CAP ON SPIKE AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO DAMAGED. THE TRANSFER SET WAS VISUALLY INSPECTED AND NOTED THAT THE SPIKE WAS BROKEN/CRACKED AT BASE OF SPIKE. A LAB (B)(4) TITANIUM ADAPTER WAS FUNCTIONALLY HAND TIGHTENED WITHOUT DIFFICULTY. THE TRANSFER SET WAS TESTED UNDERWATER WITH A LEAK NOTED AT THE CRACK IN THE SPIKE. THE COMPLAINT WAS CONFIRMED IN THE LAB. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO THE CRACK IN THE SPIKE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. 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 BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. A 510 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 NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE REPORTED A BROKEN SPIKE ON A UV-FLASH TRANSFER SET. A LEAK WAS FOUND WHILE THE PATIENT WAS CHANGING THE SOLUTION BAGS. A CRACK ON THE SPIKE WAS FOUND AFTER THE TRANSFER SET HAD BEEN CHANGED. THE TRANSFER SET WAS IN USE FOR 60 DAYS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1