BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2180361 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09808
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV): THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL PD4 UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH SINGLE DOSES OF VANCOMYCIN 2G AND CEFTAZIDIME 1G, STAT AND AS PER UNIT PROTOCOL. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2011 WITH CLOUDY EFFLUENT. ON (B)(6) 2011, THE PATIENT BEGAN ORAL TREATMENT WITH CEFTAZIDIME, HOWEVER AFTER 4 DAYS OF TREATMENT, THE PD FLUID WAS STILL CLOUDY AND ABDOMINAL PAIN CONTINUED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE REPORTING NURSE DID NOT CONSIDER THE BACTERIAL PERITONITIS TO BE SERIOUS, HOWEVER BAXTER CONSIDERED THE EVENT OF BACTERIAL PERITONITIS MEDICALLY SIGNIFICANT. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS UNKNOWN AND THE OUTCOME NOT REPORTED. THE NURSE STATED IT WAS UNKNOWN WHETHER THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM, NOT OTHERWISE SPECIFIED (NOS) WAS RELATED TO DIANEAL PD4 UNKNOWN BAG OR EXTRANEAL VIAFLEX THERAPIES.

    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 63 YR Required Intervention DIANEAL PD4 UNKNOWN BAG| EXTRANEAL VIAFLEX