BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2233359 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11642
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY BAXTER GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE WITH SUPPLEMENTAL INFORMATION FROM A PHYSICIAN FROM (B)(6) OF PERITONEAL CLOUDY EFFLUENT AND PERITONEAL EFFLUENT WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5, AND DIANEAL-N PD4 2.5 THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2000ML, DAILY, LOT NUMBER NOT REPORTED) IP FOR PD. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONEAL CLOUDY EFFLUENT; HOWEVER, ACCORDING TO THE PATIENT HE HAD BEEN EXPERIENCING PERITONEAL CLOUDY EFFLUENT SINCE THE BEGINNING OF EXTRANEAL VIAFLEX THERAPY. THE PERITONEAL CLOUDY EFFLUENT WAS WITHOUT SYMPTOMS SUCH AS ABDOMINAL PAIN OR PYREXIA. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1.5G, FREQUENCY, AND ROUTE NOT REPORTED) AS TREATMENT FOR THE PERITONEAL CLOUDY EFFLUENT. IN (B)(6) 2011, THE EVENT OF PERITONEAL CLOUDY EFFLUENT WAS RESOLVING. IT WAS NOT REPORTED WHETHER THE EVENT OF PERITONEAL EFFLUENT WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS RESOLVED. THE PHYSICIAN DID NOT CONSIDER THE EVENT TO BE PERITONITIS. EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES WERE ONGOING. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. THE PHYSICIAN STATED THAT THE EVENT OF CLOUDY PERITONEAL EFFLUENT WAS POSSIBLY RELATED TO EXTRANEAL VIAFLEX THERAPY AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE PERITONEAL CLOUDY EFFLUENT AND DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES. THE PHYSICIAN DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF PERITONEAL EFFLUENT WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL-N PD4 1.5| ALLOPURINOL| ALFACALCIDOL| ALISKIREN FUMARATE| AMLODIPINE BESILATE| SIMVASTATIN| TELMISARTAN| EXTRANEAL VIAFLEX| DIANEAL-N PD4 2.5| LANTHANUM CARBONATE HYDRATE| TIZANIDINE HYDROCHLORIDE| FUROSEMIDE