BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993099 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02031
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 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 A NURSE FROM (B)(6) OF STERILE PERITONITIS AND FEELING UNWELL IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX ,NUTRINEAL AND PHYSIONEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT DEVELOPED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, AFTER HIS EXTRANEAL VIAFLEX TREATMENT IN THE EVENING. ON (B)(6) 2011, THE PATIENT WAS FEELING UNWELL. ON (B)(6) 2011, THE PATIENT RECEIVED "2 GM VANCOMYCIN IP ON TWO OCCASIONS OVER TWO WEEKS" AND 500MG CIPROFLOXACIN "ORALLY DAILY FOR TWO WEEKS". THE NURSE REPORTED ON (B)(6) 2011, EXTRANEAL VIAFLEX AND NUTRINEAL THERAPY WERE TEMPORARILY REMOVED FROM THE PATIENT'S TREATMENT. PHYSIONEAL 1.36% AND 2.27% WERE REPORTED AS ONGOING. ON AN UNREPORTED DATE, THE NURSE REPORTED THAT THE PATIENT WAS "NOW BEING GENERALLY WELL WITH CLEAR FLUID". THE NURSE REPORTED THE EVENTS OF STERILE PERITONITIS AND FEELING UNWELL WERE RESOLVING. THE REPORTER BELIEVED THE EVENTS OF STERILE PERITONITIS AND FEELING UNWELL WERE PROBABLY RELATED TO EXTRANEAL, AND POSSIBLY RELATED TO NUTRINEAL. THE REPORTER BELIEVED PHYSIONEAL WAS UNLIKELY RELATED TO THE EVENTS.

    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 72 YR Required Intervention EXTRANEAL VIAFLEX (LOT NUMBER 10J05G41)| NUTRINEAL| PHYSIONEAL