BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2250373 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12293
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2011, A BAXTER HEALTHCARE REPRESENTATIVE CONTACTED THE PATIENT AND SPOKE TO THE PATIENT'S WIFE WHO REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2011, THE PATIENT HAD BEEN USING EXTRANEAL VIAFLEX AND HAD TO GO TO THE HOSPITAL FOR AN ILLNESS. UPON FOLLOW-UP WITH THE CONSUMER, THE ADVERSE EVENT OF ILLNESS WAS CLARIFIED TO BE PERITONITIS. THE PATIENT WAS TREATED WITH AN UNKNOWN ANTIBIOTIC IN THE EMERGENCY ROOM AND DISCHARGED HOME. THE PATIENT WAS NOT HOSPITALIZED. REMEDIAL TREATMENT OF THE UNKNOWN ANTIBIOTIC WAS STOPPED AFTER ONE WEEK AND THE PATIENT WAS SWITCHED TO VANCOMYCIN (DOSE NOT REPORTED) IP, EVERY FIVE DAYS PER INJECTION INTO THE EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2011, THE EVENT OF PERITONITIS RESOLVED. REMEDIAL TREATMENT WITH VANCOMYCIN WAS ONGOING. THE CONSUMER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 64 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX