BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 3120559 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12919
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER 12J23H17 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. DURING VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE NO ISSUES WERE NOTED. DIMENSIONAL VERIFICATION OF THE CRITICAL DIMENSIONS SHOWED THAT THE SAMPLE DID NOT MEET SPECIFICATION; THE MINICAP HAD A SLIGHT DAMAGE TO THE POSITIVE STOP, CAUSE UNDETERMINED. THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE PATIENT REPORTED THAT THE MINI CAP BECAME LOOSE AGAINST THE TRANSFER SET DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222854 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12J23H17

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE| TRANSFER SET| HOMECHOICE