BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2864821 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06841
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF BOWEL IRRITATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 1.5% ULTRABAG AND DIANEAL PD2 2.5% ULTRABAG THERAPIES. DIANEAL THERAPIES WERE ONGOING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED BOWEL IRRITATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS BOWEL IRRITATION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION AMIKACIN (500MILLIGRAM (MG),ONCE DAILY), INTRAPERITONEAL INJECTION (IP) AND REFLIN (500MG, ONCE DAILY), IP AND TABLET AUGMENTIN (325MG, TWICE DAILY), IP FOR THE PERITONITIS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME OF THE BOWEL IRRITATION WAS NOT REPORTED. THE EVENT OF PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS. A CAUSALITY ASSESSMENT FOR THE BOWEL IRRITATION WAS NOT REPORTED.

    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 14 YR Required Intervention DIANEAL PD2 2.5% ULTRABAG| DIANEAL PD2 1.5%ULTRABAG