BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3894388 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20260
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT, WHERE THE PATIENT PERFORMED A PARTIAL SWAP OF SUPPLIES. 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 INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE ANY DISPOSABLE SUPPLIES. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) REUSED SINGLE-USE SUPPLIES DURING PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING FOR AN UNRELATED ISSUE, THE PATIENT REPLACED ONE SUPPLY BAG RATHER THAN THE ENTIRE SET-UP. THE PATIENT WOULD COMPLETE THERAPY USING MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371478 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE