BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2836426 · Received November 16, 2012

    Report

    Report Number
    1416980-2012-05477
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    May 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A 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. THIS COMPLAINT FOR PERITONITIS -NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A LITERATURE REPORT FROM (B)(6) OF PERITONITIS IN A PATIENT SUBSEQUENT TO THERAPY WITH DIANEAL-N PD-2 1.5. DIANEAL-N PD-2 1.5 THERAPIES WERE ONGOING THROUGHOUT THE EVENT. ON (B)(6) 2012, THE PATIENT HAD PERITONEAL CLOUDY EFFLUENT. ON (B)(6) 2012, HE WAS DIAGNOSED WITH EOSINOPHILIC PERITONITIS AND WAS HOSPITALIZED. ABDOMEN WAS FLAT, SOFT, NON TENDER AND WITHOUT REDNESS AROUND THE CATHETER EXIT SITE. PD EFFLUENT WAS CLOUDY. THROUGHOUT THE CLINICAL COURSE, THE PATIENT DID NOT HAVE PYREXIA OR ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH PREDONINE FOR 10 WEEKS AND KETOTIFEN. THE PATIENT RECOVERED FROM THE EVENT. ON (B)(6) 2012, THE FIRST AUTHOR OF THE ARTICLE STATED THAT THE EVENT OF EOSINOPHILIC PERITONITIS WAS DEFINITELY RELATED TO DIANEAL-N PD-2 1.5 THERAPY.

    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 58 YR Hospitalization| R DIANEAL-N PD-2 1.5