BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2015484 · Received March 11, 2011

    Report

    Report Number
    1423500-2011-03042
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 17, 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 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 (B)(6) AND IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE, NAUSEA, VOMITING AND ACUTE PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD1 THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THIS IS ONE OF MULTIPLE REPORTS BY SAME REPORTER. ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2010, THE PATIENT EXPERIENCED ACUTE PERITONITIS MANIFESTED BY ABDOMINAL PAIN, NAUSEA AND VOMITING. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY VANCOMYCIN (2G, X 7 DAYS, IP) AND RIMACTAN (600MG, DAILY X 7 DAYS, PO). IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, OR IF DIANEAL PD1 THERAPY WAS ONGOING. ON (B)(6) 2010, REMEDIAL THERAPY WAS DISCONTINUED. ON AN UNREPORTED DATE, THE EVENT OF ACUTE PERITONITIS WITH (B)(6) MANIFESTED BY ABDOMINAL PAIN, NAUSEA AND VOMITING HAD RESOLVED. THE PHYSICIAN DID NOT CONSIDER THE EVENT OF ACUTE PERITONITIS WITH (B)(6) MANIFESTED BY ABDOMINAL PAIN, NAUSEA AND VOMITING TO BE RELATED TO DIANEAL PD1 THERAPY. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF 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 DIANEAL PD1 THERAPY