BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1980868 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01613
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 21, 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 IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4, EXTRANEAL VIAFLEX AND NUTRINEAL PD4. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4, UNKNOWN BAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. IT WAS NOT REPORTED WHETHER DIAGNOSTIC TESTING OR REMEDIAL THERAPY WAS RENDERED. AS OF (B)(6) 2011, THE EVENT OF PERITONITIS HAD NOT RESOLVED AND THE PATIENT REMAINED HOSPITALIZED. IT WAS NOT REPORTED WHETHER DIANEAL PD4, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 BAG THERAPIES WERE ONGOING. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE CONSIDERED THE EVENT OF PERITONITIS TO BE RELATED DIANEAL PD4, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 BAG THERAPIES.

    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 79 YR Hospitalization DIANEAL PD4| NUTRINEAL PD4| EXTRANEAL VIAFLEX