BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023751 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03377
    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 FROM (B)(6) WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN OF STERILE PERITONITIS IN COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. THIS REPORT WAS RECEIVED BY THE SWEDISH MPA AND FORWARDED TO BAXTER SWEDEN. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE AND FREQUENCY UNKNOWN) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT'S TREATMENT WITH EXTRANEAL WAS DISCONTINUED. ON (B)(6) 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS, CLOUDY EFFLUENT AND DISCOMFORT IN ABDOMEN, NOT REQUIRING HOSPITALIZATION. THE PHYSICIAN ASSESSED THE STERILE PERITONITIS AS MODERATE. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH NEBCINA (TOBRAMYCIN), 120MG, 80MG OR 60MG, AT 5 OCCASIONS (ROUTE NOT REPORTED) AND VANCOCIN (VANCOMYCIN), 1G, IP, AT 5 OCCASIONS. ON (B)(6) 2011, TREATMENT WITH VANCOCIN ENDED. ON AN UNKNOWN DATE, TREATMENT WITH NEBCINA ENDED. ON AN UNKNOWN DATE, AFTER DISCONTINUING EXTRANEAL TREATMENT, THE PATIENT RECOVERED FROM CLOUDY EFFLUENT, DISCOMFORT IN ABDOMEN AND PERITONITIS. ON AN UNREPORTED DATE IN 2011, THE PATIENT WAS RE-CHALLENGED WITH "NEW" EXTRANEAL "FROM ANOTHER COUNTRY" WITH A NEW LOT NUMBER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT WITH THE "NEW" EXTRANEAL. THE PHYSICIAN BELIEVED THE EVENT OF STERILE PERITONITIS WAS RELATED TO EXTRANEAL THERAPY. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF DISCOMFORT IN ABDOMEN. THE PHYSICIAN REPORTED THAT THE PATIENT'S CONCOMITANT MEDICATION PHYSIONEAL 35 (LOT NUMBER UNKNOWN) IS NOT SUSPECTED TO BE THE CAUSE OF THE ADVERSE EVENT AND THE PATIENT'S TREATMENT WITH PHYSIONEAL 35 WAS NOT DISCONTINUED. THE PHYSICIAN REPORTED THE EVENT OF STERILE PERITONITIS WAS RELATED TO EXTRANEAL THERAPY. THE PHYSICIAN REPORTED THAT THE PATIENT'S CONCOMITANT MEDICATION PHYSIONEAL 35 (LOT NUMBER UNKNOWN) IS NOT SUSPECTED 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 56 YR Required Intervention ZOPIKLON| PANODIL| PHYSIONEAL 35 GLUCOSE| DIMOR| OMEPRAZOLE| LOCOBASE (LACTIC ACID, PROPYLENE GLYCOL)| DALACIN| RENAGEL| HUMULIN NPH| CITALOPRAM| HUMALOG| TROMBYL| SELOKEN| KLORHEXIDINSPRIT| ETALPHA| IMPUGAN| ORALOVITE| SIMVASTATIN