BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023701 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03371
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS 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. 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 SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS COINCIDENT WITH DIANEAL PD1 AND EXTRANEAL VIAFLEX THERAPIES. THIS IS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER. ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD1 AND EXTRANEAL VIAFLEX, (DOSES, FREQUENCIES NOT REPORTED), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2009, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN. ON (B)(6) 2009, REMEDIAL TREATMENT WAS STARTED WITH ONE TIME ONLY IP INJECTIONS OF KETOCEF 1GM AND GENTAMYCIN 80MG. FROM (B)(6) 2009 THROUGH (B)(6) 2009, THE PATIENT WAS TREATED 2X/DAY IP WITH KETOCEF 375MG AND GENTAMYCIN 20MG. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS WITH (B)(6). IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. THE SEVERITY OF THE BACTERIAL PERITONITIS WAS CONSIDERED SEVERE AND THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS BREAK IN ASEPTIC TECHNIQUE. HOSPITALIZATION AND ACTION TAKEN WITH DIANEAL AND EXTRANEAL WERE NOT REPORTED. THE PHYSICIAN CONSIDERED THE EVENT OF BACTERIAL PERITONITIS WITH (B)(6) UNRELATED TO DIANEAL AND EXTRANEAL: HOWEVER, DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR BREAK IN ASEPTIC TECHNIQUE.

    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 Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD1