BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3092793 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11295
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR RENAL FAILURE CHRONIC. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY PERITONEAL CLOUDY EFFLUENT AND WAS HOSPITALIZED ON THE SAME DAY FOR THE EVENT. THE PATIENT WAS TREATED FOR PERITONITIS WITH AN UNKNOWN ANTIBIOTIC MEDICATION. THE PATIENT WAS RECOVERING FROM THE EVENT. THE PHYSICIAN ALSO STATED THAT THE PERITONITIS BACTERIAL WAS LIKELY DUE TO A BREAK IN ASEPTIC TECHNIQUE DURING THE PERITONEAL DIALYSIS PROCEDURE. ON AN UNREPORTED DATE, RETRAINING OF PROPER CONNECT/DISCONNECT METHOD AND ASEPTIC TECHNIQUE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194395 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD-4 2.5 AND EXTRANEAL VIAFLEX