BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2138398 · Received June 23, 2011

    Report

    Report Number
    1423500-2011-08263
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO SAMPLE AVAILABLE FOR EVALUATION, SO THE COMPLAINT WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. 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 SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. (B)(4).

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) FROM A NURSE. IT WAS REPORTED THAT A MALE PATIENT, WHO DIALYZED AT HOME, EXPERIENCED DIFFICULTIES CONNECTING A BAXTER ULTRAVIOLET (UV)-FLASH SOLUTION TRANSFER SET TO THE UV FLASH MACHINE. ACCORDING TO THE REPORTER, THERE WAS A BAD CONNECTION BETWEEN THE SET AND THE DIANEAL BAG, COUPLED WITH A MISSPIKING. THE SPIKE WAS FOUND TWISTED. THE REPORTER STATED THE MACHINE HAS BEEN REVIEWED WITHIN THE CENTER (BY THEIR BIOMEDICAL TEAM) AND NO ISSUE WAS FOUND, THE MACHINE IS STILL USED BY THE PATIENT. ACCORDING TO THE REPORTER, THE PATIENT WENT TO THE HOSPITAL IN ORDER TO CHANGE HIS TRANSFER SET. THE NURSE REPORTED A PERITONITIS RISK DUE TO THE SET CHANGE. THE REPORTER CONFIRMED THAT THERE WAS NO MEDICATION NOR ADDITIONAL HOSPITALIZATION FOR THE PATIENT. THERE WAS NO PROFILAXIC ANTIBIOTHERAPY PERFORMED ON THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED FOR THE PATIENT. THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ MED-TECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UV FLASH