BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 195855 · Received November 4, 1998

    Report

    Report Number
    1423500-1998-01874
    Event Type
    Injury
    Date Received
    November 4, 1998
    Date of Event
    September 21, 1998
    Report Date
    October 26, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    F/U WITH A DIALYSIS HOME PT'S WIFE REGARDING A SYSTEM ERROR 2240 ALARM REVEALED THE PT WAS HOSPITALIZED FOR PERITONITIS 10 DAYS FOLLOWING THE SYSTEM ERROR 2240 ALARM INCIDENT. THE HEALTH CARE PROFESSIONAL IS UNSURE TO WHAT THE PERITONITIS IS ATTRIBUTED, BUT SHE DOES NOT FEEL IT IS ATTRIBUTED TO THE SYSTEM ERROR 2240 ALARM INCIDENT. THE CULTURE WAS TAKEN AFTER ANTIBIOTIC THERAPY HAD BEGUN SO THE RESULTS SHOWED NO GROWTH. THE HEALTH CARE PROFESSIONAL NOTED THE PT HAS A STAPH INFECTION, HOWEVER THERE WAS NO EVIDENCE OF THAT IN THE LAB RESULTS. THE LAB RESULTS DID, HOWEVER, SHOW AN ELEVATED WHITE BLOOD CELL COUNT AND EVIDENCE OF CLOUDY FLUID. THE PT IS RESPONDING TO TREATMENT ACCORDING TO THE HEALTH CARE PROFESSIONAL, ALTHOUGH THE ANTIBIOTICS THE PT WAS TREATED WITH ARE UNK.

    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 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O