BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3140308 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13917
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INSTRUCTIONS LISTED IN THE PATIENT AT HOME GUIDE FOR THE HOMECHOICE DEVICE STATE, "DISCARD THE DISPOSABLE SET AND ALL SOLUTION BAGS AT THE END OF THERAPY. POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. CONTAMINATION OF ANY PORTION OF THE FLUID OR FLUID PATH MAY RESULT IN PERITONITIS, SERIOUS PATIENT INJURY, OR DEATH." PATIENTS ARE WARNED TO NOT RECONNECT SOLUTION BAGS, WHICH INSTRUCTS PATIENTS TO NOT REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THEIR THERAPY. IF A BAG BECOMES DISCONNECTED DURING THEIR THERAPY, THEY ARE INSTRUCTED TO FOLLOW THE INSTRUCTIONS IN THE END THERAPY EARLY PROCEDURE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM, IT WAS FOUND THAT THE REGISTERED NURSE (RN) HAD REUSED THE SETUP FROM THE PREVIOUS NIGHT FOR ANOTHER THERAPY ON THE HOME PATIENT (HP). THE THERAPY WAS THEN ENDED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242070 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE