BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 376049 · Received February 7, 2002

    Report

    Report Number
    1423500-2002-00141
    Event Type
    Other
    Date Received
    February 7, 2002
    Date of Event
    January 11, 2002
    Report Date
    January 31, 2002
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTED A HOME PATIENT WAS DIAGNOSED WITH PERITONITIS IN 2002. THE PATIENT WAS TREATED OUTPATIENT WITH 1GM LOADING DOSE FOLLOWED BY 250MG EACH EXCHANGE OF CEFAZOLIN AND 24MG LOADING DOSE FOLLOWED BY 24MG EACH EXCHANGE OF GENTAMICIN. ON 01/02, THE PATIENT WAS HOSPITALIZED AS THE PATIENT WAS UNABLE TO ADMINISTER THE MEDICATION INTO THEIR SOLUTION BAGS THEMSELVES. PER RN, THE TREATMENT DURING HOSPITALIZATION IS UNKNOWN. THE PATIENT'S CATHETER WAS REMOVED. THE RN NOTED THAT THE PATIENT HAS A HISTORY OF PERITONITIS HOWEVER, THE INFECTIOUS CONTROL DEPARTMENT OF THE HOSPITAL ADVISED RN TO NOTIFY BAXTER DUE TO THE RARITY OF THE GROWTH FROM THE CULTURE. RN ALSO NOTED THE PATIENT DOES NOT HAVE ISSUES WITH USING ASEPTIC TECHNIQUE CONSISTENTLY. THE PT WAS RELEASED FROM THE HOSPITAL 6 DAYS LATER AND HAS FULLY RECOVERED. RN REPORTED PATIENT HAS BEEN TRANSFERRED TO HEMODIALYSIS. THE RN DOES NOT ATTRIBUTE THE PATIENT'S PERITONITIS TO BAXTER PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R