BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 201802 · Received December 9, 1998

    Report

    Report Number
    1423500-1998-01998
    Event Type
    Malfunction
    Date Received
    December 9, 1998
    Date of Event
    November 11, 1998
    Report Date
    November 11, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED HOME PATIENT FELT OVERFILLED WHILE USING HIS HOMECHOICE CYCLER FOR AUTOMATED PERITONEAL DIALYSIS THERAPY. ACCORDING TO THE HEALTH CARE PROFESSIONAL, HOME PATIENT FELT PAIN DURING HIS FILL PHASE, AND PLACED THE CYCLER INTO A MANUAL DRAIN. HEALTH CARE PROFESSIONAL STATES THE HOME PATIENT DRAINED OUT A TOTAL OF 3500ML DURING THE MANUAL DRAIN, WHICH WAS ONE LITER MORE THAN HIS PROGRAMMED FILL VOLUME OF 2500ML. AFTER COMPLETING THE MANUAL DRAIN, THE HOME PATIENT CONTINUED THERAPY COMPLETION WITH NO FURTHER DIFFICULTY. HEALTH CARE PROFESSIONAL "FEELS" THAT HOME PATIENT RECEIVED AN INCOMPLETE DRAIN FOLLOWED BY A FULL FILL; HOWEVER, CANNOT PROVIDE FURTHER INCIDENT DETAILS. ACCORDING TO HEALTH CARE PROFESSIONAL, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR