BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 447231 · Received March 7, 2003

    Report

    Report Number
    1423500-2003-00214
    Event Type
    Other
    Date Received
    March 7, 2003
    Date of Event
    February 9, 2003
    Report Date
    February 9, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOME PT (HP) REPORTED FEELING OVERFILLED AND EXPERIENCED NAUSEA AND VOMITING WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HEALTHCARE PROFESSIONAL (HCP) OF THE HP RELATES THAT THE HP PERFORMS A MANUAL MIDDAY EXCHANGE OF 2000MLS, WHICH IS TYPICALLY DRAINED OUT DURING THE SUBSEQUENT INITIAL DRAIN PHASE USING THE HOMECHOICE CYCLER. THE HCP RELATES THAT THE HP, BEING ASSISTED BY FAMILY MEMBER, DID NOT FULLY DRAIN DURING THE INITIAL DRAIN AND BYPASSED THE INITIAL DRAIN AFTER 1474MLS HAD BEEN DRAINED, WHICH IS LESS THAN THE PROGRAMMED INITIAL DRAIN ALARM SETPOINT OF 1800MLS. THE HP THEN REC'D THE FIRST PREPROGRAMMED FILL VOLUME OF 2000MLS, AFTER WHICH THEY FELT OVERFILLED AND VOMITED. ACCORDING TO THE HCP, THE HP PLACED THE CYCLER INTO A MANUAL DRAIN UNTIL THEY NO LONGER FELT OVERFILLED OR NAUSEA, AFTER WHICH CONTINUED THERAPY TO COMPLETION WITH NO FURTHER DIFFICULTIES. THE HCP RELATES THAT THERE WAS NO PT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    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 54 YR Required Intervention DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2003,| 3-PRONG, 2003.| HOMECHOICE INTEGRATED APD SET WITH CASSETTE| MINICAP DISCONNECT CAP, 2003,