BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOME CHOICE AUTOMATED PD SYSTEM - 115 VOLTS

    MDR report key: 118744 · Received September 8, 1997

    Report

    Report Number
    1423500-1997-00013
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    August 7, 1997
    Report Date
    September 5, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PT DID NOT RECEIVE REPLACEMENT HOME CHOICE DEVICE FOR APD THERAPY, AS ORIGINALLY SCHEDULED, DUE TO A DELIVERY ERROR BY THE CONTRACT COURIER. AFTER (1) MISSED DIALYSIS TREATMENT, PT PRESENTED TO HOSPITAL WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED FOR 6 DAYS. (8/7-8/13). PT WAS DIALYZED IN HOSPITAL AND DRAINED OF 10 POUNDS OF FLUID WHICH HAD CONTRIBUTED TO THE SHORTNESS OF BREATH, AS THE PT HAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND RE-ABSORBS FLUID DURING THE DAY, RN ALSO NOTED PT'S TREATMENT HAD NOT YET BEEN FIRMLY ESTABLISHED AS THEY WERE STILL MONITORING HIS RE-ABSORPTION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME CHOICE AUTOMATED PD SYSTEM - 115 VOLTS PERSONAL CYCLER AUTOMATED PD SYSTEM KPF BAXTER HEALTHCARE CORP. HOME CHOICE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization