BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2060702 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04616
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 28, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD). IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS IN (B)(6) 2010. ON AN UNREPORTED DATE, THE PATIENT RECEIVED TREATMENT WITH UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. TREATMENT CONTINUED WITH DIANEAL PD4 AMBUFLEX. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE DIANEAL PD4 THERAPY.

    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 32 YR Hospitalization| R PD CYCLER| DIANEAL PD4