BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1880177 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04789
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED THROUGH SAMPLE INSPECTION. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10G24045, H10F06028, AND H10E08026) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR A FUNGAL ORGANISM IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNREPORTED. IT WAS UNREPORTED IF TREATMENT WAS PROVIDED AND IF THE PATIENT WAS HOSPITALIZED. UPON FOLLOW-UP WITH THE NURSE ON (B)(6) 2010, THE NURSE REPORTED IN (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. PD THERAPY WAS WITHDRAWN AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention