BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1802506 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02492
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 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). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR TUBING LEAKAGE DUE TO A CUT/HOLE IN THE TUBING (1 AND 5/8 INCHES FROM THE BASE OF THE WHITE TWIST SLEEVE WHEN CLOSED). THE ROOT CAUSE COULD NOT BE CONFIRMED FOR THE CUT/SLICE/HOLE IN THE TUBING.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON EVALUATION COMPLETION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AN ERROR OCCURRED WHILE THE PATIENT WAS DISCONNECTING THE SET FROM THE TWIN BAG AND CONNECTING IT TO THE DISCONNECT CAP BY CLEANFLASH. THE PATIENT CONNECTED THE SET TO THE DISCONNECT CAP BY CLEANFLASH MANUALLY. AFTER THAT, LEAKAGE FROM THE TUBING WAS FOUND. THE PATIENT USED THE CLEANFLASH ON HIS BED, SO IT WAS PLACED UNSTABLY. THIS COULD CAUSE THE ERROR, THE PATIENT THOUGHT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE WAS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT ONCE THE VOICE MESSAGE IS RECORDED THE ALARM PLAYS THE MESSAGE BACK WITH COMPLETE STATIC. THE BATTERIES HAVE BEEN CHANGED ALL OF THE SAME TYPE AND NO VISIBLE DAMAGE TO THE CASE. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION SHOWS THAT THE UNIT HAS INTERMITTENT POWER.

    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