BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3073503 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10155
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH ?THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAREGIVER DISCONNECTED AND RECONNECTED A BAG TO THE SUPPLY LINE DUE TO AN ALARM; THIS IS A USE ERROR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SETUP WAS COMPROMISED AND ASSISTED WITH ENDING THE THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173951 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE