BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DICEA-210G MULTILINGUAL HIGH PERF D

    MDR report key: 1831542 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03374
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 16, 2010
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE NOT AVAILABLE. 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 MANUFACTURING RECORDS, PROCESS INSPECTION RECORDS, AND RELEASE INSPECTION RECORDS OF THE LOT CONCERNED WERE REVIEWED AND NO DEFECT WAS FOUND. THE LOT WAS CONFIRMED TO HAVE BEEN MANUFACTURED UNDER NORMAL CONDITIONS. THE RETAINED SAMPLES OF THE LOT WERE (B)(4) FOR THE IMPLEMENTATION OF THE LEAK TEST. THE RESULT SHOWED NO FIBER LEAK.

    Description of Event or Problem · 1

    A PHYSICIAN CONTACTED THE BAXTER REPRESENTATIVE INDICATED THAT 9 UNITS WERE BROKEN AND THE PHYSICIAN WAS UNABLE TO USE THEM. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SAMPLE IS NOT AVAILABLE. THIS IS REPORT 5 OF 9 RECEIVED WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DICEA-210G MULTILINGUAL HIGH PERF D DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION USD 09E18D

    Patients

    Seq Age Sex Outcome Treatment
    1