BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2013573 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02999
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    September 1, 2010
    Report Date
    February 17, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE 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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, 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

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF PYREXIA AND STERILE PERITONITIS IN A PATIENT (IN HER (B)(6)) COINCIDENT WITH DIANEAL, UNKNOWN, AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2001, THE PATIENT BEGAN TREATMENT WITH DIANEAL (1.36% AND 2.27%) AND EXTRANEAL VIAFLEX (DOSES, FREQUENCY AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, PERITONEAL DIALYSIS (PD) THERAPY WAS DISCONTINUED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLINICAL SIGNS OF ACUTE PERITONITIS (ABDOMINAL PAIN AND PYREXIA) AND WAS DIAGNOSED WITH STERILE PERITONITIS. THE EVENT OF STERILE PERITONITIS WAS CONSIDERED SEVERE. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. FROM (B)(6) 2010 TO (B)(6) 2010, THE PATIENT RECEIVED ANTIBIOTIC TREATMENT WITH VANCOMYCIN 2 GRAMS IP (7 DAYS) AND RIMACTAN 600 MG ORALLY (PO) ONCE A DAY. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN STATED THE CAUSALITY IN RELATION TO THE EVENT OF STERILE PERITONITIS (AND PYREXIA) WITH DIANEAL AND EXTRANEAL WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL VIAFLEX| DIANEAL