BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2924074 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01514
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL 1.5% PD4 SOLUTION AND EXTRANEAL 7.5% PD2 SOLUTION THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER GLOBAL TECHNICAL SERVICES, THE FOLLOWING INFORMATION WAS RECEIVED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30080 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention EXTRANEAL 7.5% PD2 SOLUTION| DIANEAL 1.5% PD4 SOLUTION