BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4801912 · Received May 28, 2015

    Report

    Report Number
    1416980-2015-23116
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF USE ERROR WHERE A PATIENT REUSED SINGLE-USE SUPPLIES. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE THE DISPOSABLE SET MORE THAN ONCE. IT INDICATES THAT THE DISPOSABLE SET MUST BE DISCARDED AFTER EACH USE. IT WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT REUSED A SINGLE-USE PRODUCT DURING FILL ONE OF FOUR OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED TO THE MACHINE. THE PATIENT HAD REPLACED THE HEATER BAG WITHOUT SWAPPING OUT THE DISPOSABLE SET. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH CLEARING THE ALARMS. THE PATIENT WOULD START OVER WITH ALL NEW 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
    346967 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE