BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4860158 · Received June 22, 2015

    Report

    Report Number
    1416980-2015-26159
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT WHERE THE TRANSFER SET CLAMP WAS OPEN WHILE THE PATIENT WENT TO CONNECT TO THE PATIENT LINE. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING FROM THE CYCLER. IT GUIDES THE USER TO CLOSE THE TRANSFER SET PRIOR TO DISCONNECTING FROM THE PATIENT LINE OR UNCAPPING THE TRANSFER SET PRIOR TO CONNECTION. THE GUIDE WARNS THE USER TO FOLLOW ASEPTIC TECHNIQUE TAUGHT BY THE DIALYSIS CENTER WHEN HANDLING LINES TO REDUCE THE POSSIBILITY OF INFECTION. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSFER SET LEAKED DURING USE FOR PERITONEAL DIALYSIS ON THE HOMECHOICE. THE CARE GIVER REPORTED THAT WHEN THEY WENT TO CONNECT THE TRANSFER SET TO THE PATIENT LINE, THE TRANSFER SET HAD BEEN OPEN AND SOME FLUID LEAKED OUT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404161 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE