BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2050952 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04375
    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, CONSTIPATION AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES (DOSE AND FREQUENCY NOT REPORTED, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT MADE A MISTAKE, AND CONSTIPATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE AND CONSTIPATION. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2GM, STAT, ROUTE NOT REPORTED), FORTUM (1GM, STAT, ROUTE NOT REPORTED) AND AMIKACIN (500MG, STAT, ROUTE NOT REPORTED). FORTUM (1GM, DAILY, IP), AMIKACIN (500MG, STAT, ROUTE NOT REPORTED) AND AMIKACIN (250MG, DAILY, ROUTE NOT REPORTED) WAS STARTED ON AN UNREPORTED DATE. AT THE TIME OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN PROPER ASEPTIC PROCEDURE OR WHETHER THE EVENT OF PERITONITIS WAS RESOLVED. IT WAS NOT REPORTED WHETHER TREATMENT WITH VANCOMYCIN, FORTUM AND AMIKACIN CONTINUED. IT WAS NOT REPORTED WHETHER DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. THE CONSUMER DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE AND CONSTIPATION AND STATED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES. THE REPORTER ATTRIBUTED THE CAUSE OF THE PERITONITIS TO BE THE BREAK IN ASEPTIC TECHNIQUE AND THE CONSTIPATION.

    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