BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2161184 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-09009
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REGULATORY REPORT FROM (B)(4) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH NUTRINEAL PD4 UNKNOWN THERAPY. THIS REPORT WAS RECEIVED BY (B)(4) AND FORWARDED TO BAXTER (B)(4). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH NUTRINEAL PD4 UNKNOWN THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED STERILE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL THERAPY WITH VANCOMYCIN, CIPROFLOXACIN AND GENTAMYCIN (DOSES, FREQUENCIES, AND ROUTES NOT REPORTED) FOR THREE WEEKS. PER REPORTER, THE STERILE PERITONITIS RESULTED IN A PROLONGED COURSE OF TRIPLE ANTIBIOTIC TREATMENT, "A NEAR MISS," AND THE PATIENT'S PD CATHETER REMOVAL. INFORMATION PERTAINING TO HOSPITALIZATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF STERILE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT'S PD CATHETER WAS REPLACED, OR WHETHER NUTRINEAL PD4 UNKNOWN BAG THERAPY WAS RESUMED. (B)(4) DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF STERILE PERITONITIS AND THE RELATIONSHIP TO NUTRINEAL PD4 UNKNOWN THERAPY.

    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 50 YR Required Intervention NUTRINEAL PD4