BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993101 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02029
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    March 1, 2009
    Report Date
    January 27, 2011
    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 GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) EPIDERMIDIS IN A PATIENT COINCIDENT WITH DIANEAL PD1 THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THIS IS ONE OF 5 REPORTS OF BACTERIAL PERITONITIS FROM THE SAME FACILITY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2009, THE PATIENT WAS HOSPITALIZED FOR CLINICAL SIGNS OF ACUTE PERITONITIS, MANIFESTED BY ABDOMINAL PAIN CAUSED BY (B)(6) EPIDERMIDIS. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH KETOCEF (DOSE NOT REPORTED, FREQUENCY X4, IP) AND CIPROFLOXACINE (DOSE NOT REPORTED, FREQUENCY X4, IP) FOR BACTERIAL PERITONITIS. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND COMPLETED TAKING REMEDIAL THERAPY OF KETOCEF AND CIPROFLOXACINE. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL PD1 THERAPY WAS NOT REPORTED. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT OF BACTERIAL PERITONITIS AS SEVERE. THE PHYSICIAN BELIEVED THAT THE EVENT OF BACTERIAL PERITONITIS WAS NOT RELATED TO DIANEAL PD1 THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    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 Hospitalization| R DIANEAL PD1