BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1980782 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01587
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS WITH (B)(6) IN A FEMALE PATIENT (AGE NOT REPORTED) COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY (LOT NUMBER NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNSPECIFIED ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED, IP). IN (B)(6) 2011, EXTRANEAL VIAFLEX THERAPY WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WITH (B)(6) WAS ONGOING AND IMPROVED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN CONSIDERED THE EVENT OF PERITONITIS WITH (B)(6) TO BE RELATED TO EXTRANEAL VIAFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL