BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2112950 · Received June 3, 2011

    Report

    Report Number
    1423500-2011-07035
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H11B18096 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR BACTERIA COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND DIANEAL PD4 AMBUFLEX THERAPIES. ON UNREPORTED DATES, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX AND DIANEAL PD4 AMBUFLEX (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. UPON A FOLLOW-UP CALL WITH THE PATIENT'S NURSE, THE NURSE REPORTED THAT ON (B)(4) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. IT WAS UNKNOWN TO THE NURSE AS TO THE CAUSE OF THE PERITONITIS. TREATMENT INFORMATION WAS NOT REPORTED. ON (B)(4) 2011, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED SHE DOESN'T KNOW WHETHER THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR BACTERIA WAS RELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization DIANEAL PD2 AMBUFLEX| DIANEAL PD4 AMBUFLEX