BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3140194 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13899
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS THE SAME PATIENT AS IN (B)(4). IT WAS REPORTED THAT THE HEATER BAG DISCONNECTED FROM THE INTEGRATED SET DURING DWELL ONE OF FOUR ON A HOMECHOICE (HC) MACHINE. THE CAREGIVER (CG) REATTACHED THE LINE TO THE HEATER BAG. THE CG DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES THAT WOULD HAVE CAUSED THE DISCONNECTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG IN ENDING THERAPY. 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
    241663 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR UNKNOWN PD SOLUTION| HOMECHOICE