BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 511554 · Received February 10, 2004

    Report

    Report Number
    1423500-2004-00119
    Event Type
    Injury
    Date Received
    February 10, 2004
    Date of Event
    January 25, 2004
    Report Date
    January 30, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT'S FAMILY MEMBER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOME PATIENT'S HOMECHOICE MACHINE DURING THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY IN 2004. REPORTEDLY, A SUPPLY BAG BECAME DISCONNECTED FROM THE SUPPLY LINE OF THE HOMECHOICE SET FOR AN UNKNOWN REASON DURING THERAPY, HOWEVER, THERAPY WAS COMPLETED BY SETTNG UP WITH NEW SUPPLIES. THE HOME PATIENT PRESENTED TO THE E.R. WITH ABDOMINAL PAIN, VOMITING, AND FEVER. THE HOME PATIENT WAS DIAGNOSED WITH PERITONITIS AND ADMITTED TO THE HOSP. EFFLUENT CULTURES WERE TAKEN IN 2004 CONFIRMING THE DIAGNOSIS OF PERITONITIS. MEDICATION AND TREATMENT ARE UNKNOWN AS THE HOME PATIENT WAS HOPITALIZED. BASED ON A FOLLOW-UP CULTURE THE FOLLOWING MONTH , IT WAS CONCLUDED THAT THE HOME PATIENT HAD FULLY RECOVERED FROM THE INFECTION AND THEY WERE DISCHARGED FROM THE HOSP 8 DAYS AFTER ADMISSION.

    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 11 YR Hospitalization| R DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2004.| CAPD TRANSFER SET, 2004.| 15 LITER DRAINAGE BAG, 2004.| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2004.