BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1840527 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03605
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    February 1, 2010
    Report Date
    August 31, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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 PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF SOLUTION CHANGING TECHNIQUE (CODED TO PERITONEAL DIALYSIS COMPLICATION) AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6). THE CAUSE OF THE PERITONITIS WAS SOLUTION CHANGING TECHNIQUE. THE PATIENT WAS HOSPITALIZED FROM (B)(6)2010 THROUGH (B)(6)2010. IT IS UNKNOWN IF THE PD THERAPY WAS ONGOING. THE PATIENT HAD RECOVERED FROM THE 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 Hospitalization| R DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX