BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2097731 · Received May 20, 2011

    Report

    Report Number
    1423500-2011-06264
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH FOLLOW UP INFORMATION FROM A NURSE FROM THE USA OF GASTROINTESTINAL DISTRESS IN A FEMALE (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER 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. THE CAUSE OF PERITONITIS WAS UNKNOWN TO THE CONSUMER. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT INFORMATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE DIANEAL THERAPY WAS WITHDRAWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. AN OPINION OF CAUSALITY WAS NOT PROVIDED. FOLLOW-UP INFORMATION ((B)(4) 2011): FOLLOW-UP RECEIVED FROM THE PD NURSE. THIS CASE WAS MEDICALLY CONFIRMED. ADVERSE EVENT AND HOSPITALIZATION INFORMATION, LABS, OUTCOME AND CAUSALITY WERE ADDED OR REVISED. THE ADVERSE EVENT OF PERITONITIS WAS AMENDED TO GASTROINTESTINAL DISTRESS. THE NURSE REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED NAUSEA AND VOMITING AND WAS DIAGNOSED WITH GASTROINTESTINAL DISTRESS. THE PATIENT WAS NOT HOSPITALIZED. ON AN UNKNOWN DATE, THE PATIENT RECOVERED. ON (B)(6) 2011, THE PATIENT WAS WITHDRAWN FROM PD THERAPY DUE TO A LOW ALBUMIN LEVEL AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE NURSE REPORTED THAT THE EVENT OF GASTROINTESTINAL DISTRESS WAS NOT RELATED TO DIANEAL THERAPY

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 AMBUFLEX