BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2050797 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04372
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 26, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX, (DOSES AND FREQUENCIES WERE NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS THE "PATIENT MADE A MISTAKE?. ON (B)(6) 2011 THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (2GM, LOADING DOSE, IP) AND AMIKACIN (500MG, LOADING DOSE, IP) BUT CONTINUED ON WITH FORTUM (1GM, DAILY, IP) AND AMIKACIN (250MG, DAILY, IP). DIANEAL AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED; THEREFORE THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL AND EXTRANEAL THERAPIES, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 61 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD2 ULTRABAG