BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 715626 · Received May 11, 2006

    Report

    Report Number
    1423500-2006-00580
    Event Type
    Malfunction
    Date Received
    May 11, 2006
    Date of Event
    March 1, 2006
    Report Date
    March 16, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CAP SEPARATED FROM THE BLUE AND WHITE FEMALE CONNECTOR OF THE TRANSFER SET AFER USE, AND A CLAMP HAD TO BE USED TO CLOSE CATHETER. THIS EVENT SPECIFICALLY REFERS TO AN INSTANCE FROM THE WEEK OF 03/01/2006 - 03/07/2006. DURING A FOLLOW-UP CALL WITH THE HOME PATIENT'S DAUGHTER 3 DAYS LATER, THE FHOME PATIENT DAUGHTER REPLACED THE TRANSFER SET IN THE HOME HERSELF AFTER CATHETER/TRANSFER SET SEPARATION. PD PATIENTS ARE TRAINED TO CLOSE THE CLAMP, NOT COMPLETE THE XCHANGE AND TO CAL THE DIALYSIS UNIT WHEN THIS OCCURS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED DUE TO THIS INCIDENT.

    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 72 YR