BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3041577 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08777
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAME PATIENT AS (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H12L13013 AND H13A09087 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY. DIANEAL THERAPY WAS ONGOING. THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY FOR THE EVENT OF PERITONITIS. DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. ON A SEPARATE DAY, HE PATIENT WAS ADMITTED TO THE HOSPITAL FOR COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PERITONITIS WAS NOT RESOLVED. PD THERAPY CONTINUED DURING THE PATIENT'S HOSPITALIZATION. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY DURING THE HOSPITALIZATION. THE PATIENT WAS DISCHARGED HOME. PER THE PD NURSE, THE PERITONITIS WAS CONSIDERED TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143380 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R 1.5% AND THE 2.5% LOW CAL DIANEAL