BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 2331556 · Received November 10, 2011

    Report

    Report Number
    1423500-2011-14726
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    September 25, 2011
    Report Date
    September 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    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 OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED IN THE QUALITY ENGINEERING LAB. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A CRACK HAS BEEN FOUND ON THE MINICAP. AFTER DOING THE LEAKING TEST, WE FOUND THAT THE MINICAP WAS LEAKING. THE REPORTED PROBLEM WAS CONFIRMED AND THIS DEFECT WAS CAUSED BY OUR MINICAP SUPPLIER DURING THE MANUFACTURE PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH GZP-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A MINICAP RECEIVED FOR AN INITIALLY REPORTED EVENT OF POVIDONE/IODINE LEAK, A CRACK WAS FOUND. THE INITIAL REPORT INDICATED THAT THE LEAKAGE HAD OCCURRED DURING TIGHTENING OF THE MINICAP WITH TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR ADVERSE EVENT IS REPORTED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1102002

    Patients

    Seq Age Sex Outcome Treatment
    1