BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 670153 · Received January 30, 2006

    Report

    Report Number
    1423500-2006-00141
    Event Type
    Injury
    Date Received
    January 30, 2006
    Date of Event
    September 25, 2005
    Report Date
    January 20, 2006
    Manufacturer
    MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A RELOAD SET 161 ALARM THAT APPEARED ON THE DISPLAY OF THE HOME PT'S HOMECHOICE MACHINE DURING SETUP PRIME. PER INITIAL REPORT, BAXTER'S TECHNICAL SERVICE CENTER ASSISTED ENDING THERAPY EARLY. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER WAS CONTACTED BY HP'S NURSE, WHO STATED THE HP WAS DIAGNOSED WITH PERITONITIS IN 2005 AND HOSPITALIZED FOR ONE WEEK. HP'S ESRD IS SECONDARY TO FSGS. HP'S OTHER MEDICAL HISTORY INCLUDES A CLOSED INJURY FROM A CAR ACCIDENT WHEN 5 YEARS OLD AND HYPERTENSION. HP'S SYMPTOMS WERE ABDOMINAL PAIN, CLOUDY EFFLUENT, AND VOMITING. HP IS ALLERGIC TO CEPHALOSPORIN. HP WAS TREATED WITH VANCOMYCIN IP 20 MG/L NIGHTLY FROM 2005 TO AN UNK DATE, CEFTAZIDIME IP 125 MG/L FOR AN UNK DATE RANGE, AND TOBRA IP 8 MG/L THE FOLLOWING MONTH UNTIL AN UNK DATE. THE NURSE ALSO STATED THAT THE SUSPECTED ROOT CAUSE IS PT CONTAMINATION. THE HP DID RECOVER FROM THIS PERITONITIS BASED ON CELL COUNTS. THE NURSE ALSO STATED THAT SHE THOUGHT THIS INVESTIGATION WAS A WASTE OF TIME SINCE THE RELOAD SET ALARM OCCURRED AFTER THE PT WAS........

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX MOUNTAIN HOME NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R CAPD TRANSFER SET| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT| DIANEAL SOLUTION (STRENGTH UNK)