BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2091721 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06081
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 24, 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. THE CAUSE WAS DUE TO USE ERROR, POOR ASEPTIC TECHNIQUE. 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 CONSUMER REPORT FROM (B)(4) OF AREA WAS NOT CLEAN AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG 2.5%, (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IN 2011, THE AREA WAS NOT CLEAN BEFORE STARTING PD. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED. ON THIS SAME DATE, PRIOR TO INITIATING ANTIBIOTIC THERAPY, A SAMPLE OF PERITONEAL EFFLUENT WAS ANALYZED AND CULTURED. THE RESULTS OF THE ANALYSIS WERE TO FOLLOW. THE RESULT OF THE CULTURE WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH REFLIN 1 GM ONCE DAILY IP, TOBRAMYCIN 40 MG ONCE DAILY IP AND HEPARIN 1000 IU, ONCE DAILY IP. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE, THE OUTCOME FOR THE EVENT OF AREA WAS NOT CLEAN WAS UNKNOWN. AT THE TIME OF REPORTING, THE EVENT OF PERITONITIS WAS RESOLVING AND THE PATIENT CONTINUED TO RECEIVE REFLIN, TOBRAMYCIN AND HEPARIN. DIANEAL THERAPY CONTINUED. THE REPORTER BELIEVED THAT THE EVENTS OF THE AREA WAS NOT CLEAN BEFORE STARTING PD AND PERITONITIS WERE UNRELATED TO DIANEAL THERAPY.

    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 55 YR Hospitalization| R DIANEAL PD2 ULTRABAG 2.5%