BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1940264 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07349
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 10, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CLOUDY DIALYSATE AND RECEIVED UNSPECIFIED ANTIBIOTIC THERAPY (DOSE, FREQUENCY AND ROUTE NOT REPORTED). ON AN UNREPORTED DATE, THE UNSPECIFIED ANTIBIOTIC WAS DISCONTINUED. NUTRINEAL PD4 UNKNOWN BAG WAS DISCONTINUED AND REPLACED WITH PHYSIONEAL, UNSPECIFIED PRODUCT 1.36% ON AN UNREPORTED DATE. EXTRANEAL VIAFLEX CONTINUED AT THE SAME DOSE AFTER CAREFUL CONSIDERATION. AN OUTCOME FOR THE EVENT OF CLOUDY DIALYSATE WAS NOT REPORTED. THE PHYSICIAN DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF CLOUDY DIALYSATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL VIAFLEX AND NUTRINEAL PD4