BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2020733 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03270
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    September 1, 2010
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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 IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS ("STAPH") IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG AND DIANEAL PD4 ULTRABAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS AND WAS HOSPITALIZED. IT WAS NOT REPORTED IF REMEDIAL TREATMENT WAS RENDERED. ON AN UNREPORTED DATE, THE PATIENT WAS TRANSFERRED TO HAEMODIALYSIS (HD). ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. 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 UNKNOWN. THE OUTCOME FOR BACTERIAL PERITONITIS AND ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. THE NURSE BELIEVED THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS ("STAPH") WAS UNRELATED TO DIANEAL THERAPIES. THE NURSE 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 58 YR Hospitalization DIANEAL PD2 ULTRABAG| DIANEAL PD4 ULTRABAG