BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP W / PVP - I SOLUTION

    MDR report key: 1862688 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04251
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    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 AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT THAT THE SPONGE DROPPED OUT OF THE MINICAP WAS CONFIRMED BASED ON SAMPLE EVALUATION. NO ISSUES WERE NOTED IN THE BATCH FILE REVIEW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. NO ROOT CAUSE RELATING TO THE MANUFACTURING PROCESS HAS BEEN DETERMINED AND NO CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE SPONGE DROPPED OUT OF THE MINICAP PRIOR TO USE. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP W / PVP - I SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 09I14H15

    Patients

    Seq Age Sex Outcome Treatment
    1