BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2882676 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07902
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF USE ERROR ? REUSE OF SINGLE-USE SUPPLIES WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(60 2012, A NURSE REPORTED THAT AN UNIDENTIFIED PATIENT HAD A CHECK HEATER LINE ALARM ON THE HOMECHOICE MACHINE ON AN UNREPORTED DATE. THE PATIENT REPLACED THE BAG AND CONTINUED THERAPY WITHOUT CHANGING THE OTHER SUPPLIES AND WITHOUT FURTHER ISSUES OR ALARMS. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE