BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 512636 · Received February 20, 2004

    Report

    Report Number
    1423500-2004-00137
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 25, 2004
    Report Date
    January 25, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT (HP) REPORTED FEELING ABDOMINAL PAIN, AS IF THEY WERE OVERFILLED, WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP REPORTED THEY HAD APPROX 2000MLS IN THEIR PERITONEUM AT THE TIME THEY STARTED APD THERAPY. THE HP REPORTED THAT THE DEVICE REMAINED IN THE INITIAL DRAIN FOR A BRIEF TIME ONLY BEFORE ADVANCING INTO FILL. THE HP RECEIVED THE FILL AND THERAPY ADVANCED INTO DWELL, AT WHICH TIME THEY FELT OVERFILLED. THE HP DRAINED 1293MLS OF FLUID UNTIL THEY FELT RELIEVED, AFTER WHICH THEY CONTINUED APD THERAPY. REVIEW OF THE HP'S PROGRAM PARAMETERS REVEALED THAT ALTHOUGH THEY STARTED THE APD THERAPY WITH FLUID IN THEIR PERITONEUM, THE INITIAL DRAIN ALARM SETPOINT WAS PROGRAMMED AT 0MLS. THE HP HAD BEEN PREVIOUSLY ADVISED TO CONTACT THEIR HEALTHCARE PROFESSIONAL (HCP) IN ORDER TO INCREASE THE INITIAL DRAIN ALARM SETPOINT, HOWEVER, THE HP HAD NOT. THERE WAS NO RESULTING PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other DIANEAL LOW CALCIUM SOLUTION (STRENGHT UNK), 2004.| 3-PRONG, 2004.| HOMECHOICE INTEGRATED APD SET WITH CASSETTE| MINICAP DISCONNECT CAP, 2004.