BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 172242 · Received June 9, 1998

    Report

    Report Number
    1423500-1998-01393
    Event Type
    Malfunction
    Date Received
    June 9, 1998
    Date of Event
    April 1, 1998
    Report Date
    May 12, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS HOME PT HAS COMPLAINED OF EXCESS AIR IN HER PERITONEUM ON DIFFERENT OCCASSIONS. SPECIFIC INCIDENT DETAILS ARE UNK. BUT HEALTH CARE PROFESSIONAL STATES AN X-RAY CONFIRMED AIR IN THE PERITONEUM ON ONE OCCASSION. HEALTH CARE PROFESSIONAL STATES SHE BELIEVES EXCESS AIR IS DUE TO HOME PT'S IMPROPER PRIMING OF THE PT LINE TUBING OF HOMECHOICE SET. PER HEALTH CARE PROFESSIONAL, THERE WAS NO PT INJURY AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA02

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR