BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2179850 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09652
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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). A BATCH REVIEW WAS NOT PERFORMED AS A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    ON AN UNREPORTED DATE, THE (B)(6) PATIENT BEGAN DIANEAL THERAPY INTRAPERITONEALLY FOR CHRONIC RENAL FAILURE. ON (B)(6) 2011, A FAMILY MEMBER CALLED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED: ON THE EVENING ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONEAL CLOUDY EFFLUENT WHICH WAS RESULTED IN DIAGNOSIS OF PERITONITIS AND THE PATIENT WAS HOSPITALIZED. CONCOMITANT MEDICATION WAS NOT PROVIDED. AN OPINION ON CAUSALITY WAS NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE PHYSICIAN REPORTED: THE SUSPECT PRODUCTS WERE SPECIFIED TO BE DIANEAL-N PD-4 1.5 AND EXTRANEAL. THE MALE PATIENT WAS IN HIS (B)(6). ON (B)(6) 2010, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 AND EXTRANEAL. UNSPECIFIED ANTIBIOTIC THERAPY WAS ADMINISTERED. THE OUTCOME WAS NOT REPORTED. DIANEAL-N PD-4 1.5 AND EXTRANEAL THERAPIES WERE UNCHANGED AND ONGOING. THE PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD-4 1.5 OR EXTRANEAL THERAPY. THE PHYSICIAN DECLINED TO PROVIDE FURTHER INFORMATION.

    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 50 YR Hospitalization| R HOMECHOICE| DIANEAL- N PD-4 1.5| EXTRANEAL