BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2163774 · Received July 15, 2011

    Report

    Report Number
    1423500-2011-09070
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER IS UNKNOWN, THEREFORE NO BATCH REVIEW WAS PERFORMED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A CALL ON (B)(6) 2011, THE (B)(6) NURSE REPORTED TO THE BAXTER (B)(4) TECHNICAL SERVICE CENTER THAT A PATIENT HAD CLOUDY PERITONEAL EFFLUENT WITH SOMETHING FLUFFY NOTED IN THE SAMPLE. THE NURSE ADVISED THE PATIENT TO CONSULT WITH THE PHYSICIAN. CONCOMITANT MEDICATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL THERAPY. DURING A FOLLOW UP CALL ON (B)(6) 2011, SUSPECT PRODUCTS WERE SPECIFIED AS DIANEAL-N PD-2 1.5. THE PATIENT WAS A MALE IN HIS (B)(6). ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL-N PD-2 1.5. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR LARGE INTESTINE CARCINOMA. ON (B)(6) 2011, DURING THE HOSPITALIZATION, THE PATIENT DEVELOPED PERITONITIS. UNSPECIFIED ANTIBIOTICS WERE ADMINISTERED. THE PATIENT OUTCOME WAS UNKNOWN. DIANEAL-N PD-2 1.5 THERAPY WAS UNCHANGED AND ONGOING. THE PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD-2 1.5. THE PHYSICIAN INDICATED THE EVENT MIGHT BE ENDOGENOUS PERITONITIS DUE TO IMMUNOSUPPRESSION FROM AND PROGRESSION OF LARGE INTESTINAL CARCINOMA. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE| DIANEAL-N PD-2 1.5.