BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2022693 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03334
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 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.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS. ON (B)(6) 2011, THE PATIENT PRESENTED AT THE HOSPITAL EXPERIENCING CLOUDY FLUID WITH NO OTHER SYMPTOMS. ON (B)(6) 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS NOT HOSPITALIZED. THE SEVERITY OF THE PERITONITIS WAS CONSIDERED MODERATE. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH VANCOMYCIN 2G, EVERY 3 TO 6 DAYS FOR 2 WEEKS "AS PER LEVELS" AND GENTAMYCIN 30MG, EVERY DAY FOR 2 WEEKS "AS PER LEVELS." IN (B)(6) 2011, AFTER 6 DAYS OF ANTIBIOTIC TREATMENT, DIANEAL AND EXTRANEAL THERAPY WAS DISCONTINUED AND IMPORTED DIALYSIS FLUIDS FROM (B)(4) WERE INTRODUCED. ON (B)(6) 2011, THE PATIENT RECOVERED FROM STERILE PERITONITIS. ON (B)(6) 2011, THE PATIENT'S REMEDIAL TREATMENT ENDED. THE ROOT CAUSE OF PERITONITIS WAS UNKNOWN. THE NURSE BELIEVED THE EVENT OF STERILE PERITONITIS WAS RELATED TO DIANEAL AND EXTRANEAL 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 88 YR Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD4 UNKNOWN BAG