BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP

    MDR report key: 695029 · Received July 8, 2005

    Report

    Report Number
    1423500-2005-00979
    Event Type
    Malfunction
    Date Received
    July 8, 2005
    Date of Event
    June 13, 2005
    Report Date
    June 28, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED, "A PATIENT NEEDED TO REPLACE THE TRANSFER SET, BECAUSE THE OCCLUDER FEET ARE BROKEN. LEAKS CAN BE OBSERVED WHEN THE MINICAP IS REMOVED. THE REPORTED TRANSFER SET WAS PLACED IN 05/2005." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT ACCORDING TO BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP TRANSFER SET KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR