BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2141342 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08390
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    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 PD4 AMBUFLEX (SOLUTION SYS II W/ 1.5% GLUCOSE) AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONTIS WAS UNKNOWN. WHETHER REMEDIAL TREATMENT WAS RENDERED, THE OUTCOME OF THE EVENT OF PERITONITIS, AND ACTION TAKEN WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX WERE NOT REPORTED. A CAUSALITY ASSESSMENT WAS NOT PROVIDED.

    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 Other EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX (SYS II W/ 1.5% GLUCOSE)