BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2097157 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05134
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    July 31, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING SUBMITTED AS PART OF RETROSPECTIVE SUMMARY REPORT # (B)(4) THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED ON THIS MDR ARE 753 - "FKX REPORTABLE DEATH AND SERIOUS INJURIES") THESE REPORTS ARE BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING-LETTER (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNK AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNK, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, DURING A FOLLOW UP WITH THE HOME PT'S NURSE, IT WAS INDICATED THAT THE HOME PT DEVELOPED PERITONITIS ON (B)(6) 2008. THE HOME PT HAD ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008. THE HOME PT WAS PUT ON ANCEF AND FORTAZ IN THE HOSPITAL, 1G INTRAPERITONEAL ONCE A DAY. THE HOME PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2008 AND TAKEN OFF OF THE ANCEF, BUT CONTINUED TAKING THE FORTAZ UNTIL (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY/FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R HOMECHOICE CYCLER | HOMECHOICE CYCLER