BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 797408 · Received December 4, 2006

    Report

    Report Number
    1423500-2006-01258
    Event Type
    Injury
    Date Received
    December 4, 2006
    Date of Event
    November 5, 2006
    Report Date
    November 5, 2006
    Manufacturer
    MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER'S MEDICAL DIRECTOR'S MEDICAL ASSESSMENT: WHETHER A SET USED PRIOR TO THE PT'S PERITONITIS COULD BE LINKED TO THIS EPISODE OF PERITONITIS IS NOT KNOWN, BUT THERE IS NO INFO TO REASONABLY SUGGEST SO. OF NOTE, PERITONITIS IS A WELL-ESTABLISHED COMPLICATION IN PTS ON PERITONEAL DIALYSIS AND IS MOST COMMONLY RELATED TO ENTRANCE OF BACTERIA VIA THE PT'S PD CATHETER DUE TO TOUCH CONTAMINATION (USER ERROR). IN THIS CASE, IT IS MORE LIKELY, HOWEVER, THAT A DIFFERENT TYPE OF USER ERROR WAS THE CAUSE OF THE BREAK IN STERILITY, THAT BEING THE ACCIDENTAL DISCONNECTION OF THE SUPPLY LINE. THIS IS A POSSIBLE CAUSE OF THE PERITONITIS.

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SVC CENTER REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOME PT'S HOMECHOICE MACHINE DURING DWELL 2/4 OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, THE HOME PT ACCIDENTALLY DISCONNECTED A SUPPLY LINE FROM A SUPPLY BAG. BAXTER'S TECHNICAL SERVICE CTR ASSISTED THE HOME PT IN ENDING THE THERAPY EARLY. THE HOME PT WAS DIAGNOSED WITH PERITONITIS TWO DAYS LATER. THE HOME PT'S SYMPTOMS WERE ABDOMINAL PAIN, FEVER, AND CLOUDY EFFLUENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX MOUNTAIN HOME NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR CAPD TRANSFER SET| DIANEAL PD II SOLUTION (STRENGTH UNK)| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT