BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3093263 · Received May 5, 2013

    Report

    Report Number
    1416980-2013-11361
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP WAS OBSERVED TO BE DRIED OUT. THIS WAS FOUND PRIOR TO USE, IN ASSOCIATION WITH PERITONEAL DIALYSIS (PD) THERAPY. THE COLOR OF THE IODINE SPONGE WAS OBSERVED TO BE YELLOW, INSTEAD OF DARK BROWN. THE MINICAP WAS NOT USED AND THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT. THIS IS REPORT 5 OF 13 FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196028 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893883

    Patients

    Seq Age Sex Outcome Treatment
    1