BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961417 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00621
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS CAPRAE IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. IN (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH AN UNSPECIFIED ANTIBIOTIC REGIMEN (DOSE AND FREQUENCY NOT REPORTED, IP). THE PHYSICIAN STATED THAT THE PLAN WAS TO TRANSFER THE PATIENT TO HEMODIALYSIS IN THE MIDDLE OF (B)(6) 2011. IT WAS NOT REPORTED WHETHER EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE EVENT OF BACTERIAL PERITONITIS HAD NOT RESOLVED. THE PHYSICIAN CONSIDERED THE EVENT OF BACTERIAL PERITONITIS TO BE POSSIBLY RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. UPON FOLLOW-UP WITH THE PHYSICIAN ON (B)(4) 2011, IT WAS FOUND THE PATIENT IMPROVED WITH THE UNSPECIFIED ANTIBIOTIC REGIMEN. THE EVENT OUTCOME OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS CAPRAE WAS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention EXTRANEAL VIAFLEX AND PHYSIONEAL