BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023704 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03373
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A REGULATORY REPORT WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM SWEDEN OF EFFLUENT "LOOKED DIFFERENT" AND STERILE PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. THIS REPORT WAS RECEIVED BY THE SWEDISH MPA AND FORWARDED TO BAXTER SWEDEN. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE AND FREQUENCY UNKNOWN) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT PRESENTED TO THE CLINIC EXPERIENCING ABDOMINAL PAIN, AND CLOUDY EFFLUENT WHICH ACCORDING TO PHYSICIAN "MIGHT HAVE STARTED SOME DAY EARLIER." THE PHYSICIAN REPORTED THE SEVERITY OF THE STERILE PERITONITIS AS MODERATE. ON THAT SAME DAY, THE PATIENT WAS "ASSESSED WITH STERILE PERITONITIS CAUSED BY EXTRANEAL." ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL TREATMENT WITH VANCOCIN AND NEBCINA (DOSE, ROUTE AND FREQUENCY NOT REPORTED). ON AN UNKNOWN DATE, EXTRANEAL THERAPY WAS DISCONTINUED. THE PHYSICIAN REPORTED "THE PATIENT'S CONDITION IMPROVED AFTER THE DISCONTINUATION OF EXTRANEAL." THE PATIENT WAS NOT HOSPITALIZED, AND "RECOVERED AFTER A FEW DAYS" (DATE UNSPECIFIED). ON AN UNREPORTED DATE, THE PATIENT'S SYMPTOMS ABATED. EXTRANEAL THERAPY WAS NOT RE-CHALLENGED. THE PHYSICIAN REPORTED THAT CONCOMITANT MEDICATION PHYSIONEAL 35 (DOSE, FREQUENCY, LOT NUMBER UNKNOWN) WAS "NOT DISCONTINUED." THE PHYSICIAN REPORTED THE EVENT OF STERILE PERITONITIS WAS RELATED TO EXTRANEAL VIAFLEX THERAPY, AND DID NOT REPORT A CAUSALITY ASSESSMENT FOR THE EVENT OF EFFLUENT LOOKED DIFFERENT. THE PHYSICIAN DID NOT SUSPECT CONCOMITANT MEDICATION PHYSIONEAL 35 TO BE THE CAUSE OF THE ADVERSE EVENT.

    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 73 YR Required Intervention APROVEL| ORALOVITE| PRIMPERAN| ARANESP| DUROFERON| SIMVASTATIN| RENAGEL| DEXOFEN (DEXTROPROPOXYPHENE)| ETALPHA| PHYSIONEAL 35 GLUCOSE| CALCITUGG| OMEPRAZOL| KLORHEXIDIN| TROMBYL| ALVEDON ORODISPERSIBLE (PARACETAMOL)| FOLACIN| TAVEGYL (CLEMASTINE FUMARATE)