BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993122 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02036
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 26, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY AN NURSE FROM THE (B)(6) OF AN ACUTE INFECTION, DECLINED COGNITIVE BEHAVIOR ,POOR MOBILITY, RESPIRATORY PROBLEM AND SUSPECT STERILE PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, PHYSIONEAL, UNSPECIFIED PRODUCT, AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR AN ACUTE INFECTION WITH AN UNCLEAR CAUSE, DECLINED COGNITIVE BEHAVIOR, AND POOR MOBILITY. ON (B)(6) 2011, THE PATIENT EXPERIENCED SUSPECTED STERILE PERITONITIS. THE PATIENT WAS NOT TREATED WITH ANY ANTIBIOTICS THERAPY. ON AN UNREPORTED DATE IN 2011, PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS MOVED TO PALLIATIVE CARE. UPON FOLLOW UP ON (B)(6) 2011, THE NURSE STATED THAT IT WAS UNCLEAR WHETHER THE ACUTE INFECTION THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR WAS RELATED TO THE STERILE PERITONITIS. THE PATIENT'S HEALTH CARE PROFESSIONALS BELIEVED THERE WAS A "RESPIRATORY PROBLEM" HOWEVER THEY WERE NOT SURE WHETHER IT WAS LINKED TO THE STERILE PERITONITIS. THE PATIENT'S DIALYSIS WAS NOT DISCONTINUED BECAUSE OF THE SUSPECTED PERITONITIS BUT RATHER DUE TO THE SWITCH TO PALLIATIVE CARE. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND EXPECTED TO REMAIN THERE INDEFINITELY AND WOULD NOT BE RETURNING TO ANY FORM OF DIALYSIS. IT WAS NOT REPORTED WHETHER THE EVENTS OF SUSPECT STERILE PERITONITIS, ACUTE INFECTION, DECLINED COGNITIVE BEHAVIOR, POOR MOBILITY AND RESPIRATORY PROBLEM RESOLVED. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF SUSPECT STERILE PERITONITIS, ACUTE INFECTION, DECLINED COGNITIVE BEHAVIOR, POOR MOBILITY AND RESPIRATORY PROBLEM.

    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 86 YR Required Intervention EXTRANEAL VIAFLEX| NUTRINEAL PD4| PHYSIONEAL