BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 277661 · Received May 12, 2000

    Report

    Report Number
    1423500-2000-00604
    Event Type
    Injury
    Date Received
    May 12, 2000
    Date of Event
    April 13, 2000
    Report Date
    April 13, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) REPORTS ABDOMINAL PAIN DURING DWELL 1/4 OF AUTOMATED PERITONEAL DIALYSIS THERAPY. HP REPORTS CALLING DR AND WAS INSTRUCTED TO GO TO HOSP. RN REPORTS HP WAS ADMITTED INTO HOSP ON 4/14/2000, WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH ANTIBIOTICS. RN REPORTS HP WAS RELEASED THAT DAY ON 4/14/2000, AND WAS PLACED ON A THERAPY OF ANCEF 1 GM AND GENTAMICIN 80 MG, BOTH I.P. FOR 10 DAYS. RN REPORTS NO CULTURE WAS DRAWN AND THE ROOT CAUSE OF THE PERITONITIS CANNOT BE DETERMINED. RN NOTED THAT HP MAY NOT HAVE USED PROPER ASEPTIC TECHNIQUE WHILE CONNECTING TO AND FROM THE HOMECHOICE SET DURING TREATMENT ON 4/13/2000. RN REPORTS HP HAS RESPONDED TO TREATMENT. NO PRODUCT FAILURE REPORTED BY RN.

    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 50 YR Hospitalization| O