BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1935237 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07134
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 3, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM 1GM, ONCE DAILY, IP; AND REFLIN 1GM, ONCE DAILY, IP. AT THE TIME OF THIS REPORT, THE ANTIBIOTIC THERAPY AND THE DIANEAL THERAPY WERE ONGOING. THE CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. THE OUTCOME OF THE EVENT OF PERITONITIS WAS REPORTED AS RESOLVING. THE CONSUMER DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention DIANEAL PD2 ULTRABAG