BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2091545 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06065
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE CAUSE IS USE ERROR- POOR ASEPTIC TECHNIQUE. 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 SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2011, THE PATIENT PERFORMED PD THERAPY WITHOUT WEARING A MASK. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT DID NOT WEAR A MASK. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORZID (1GM, FOR 14 DAYS, ROUTE NOT REPORTED) AND REFLIN (1GM, FOR 14 DAYS, ROUTE NOT REPORTED). IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE. THE NURSE STATED THAT THE OUTCOME FOR THE EVENT OF PERITONITIS WAS "UNDER TREATMENT." IT WAS NOT REPORTED WHETHER DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE NURSE STATED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 ULTRABAG THERAPY AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF DID NOT WEAR A MASK.

    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 32 YR Required Intervention DIANEAL PD2 ULTRABAG