BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3160066 · Received June 10, 2013

    Report

    Report Number
    1416980-2013-14879
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE OCCURRENCE DATE OF THIS EVENT IS UNKNOWN, HOWEVER IT WAS REPORTED THE EVENT TOOK PLACE IN (B)(6) 2013. 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. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H13A21066 AND H13B08046. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260679 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOMECHOICE, EXTRANEAL,| DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG