BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2091694 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06070
    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
    RP
    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 OF THE PERITONITIS WAS 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 REPORT BY A CONSUMER FROM (B)(6) OF A PATIENT DID NOT WEAR A MASK AND BREAK IN ASEPTIC TECHNIQUE, FEVER AND PERITONITIS COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 1.5% AND 4.25% UNKNOWN BAG (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2011, THE PATIENT DID NOT WEAR A MASK AND HAD A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY SIGNS AND SYMPTOMS OF FEVER, ABDOMINAL PAIN, CLOUDY EFFLUENT AND THE PRESENCE OF FIBRIN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH CLARITHROMYCIN 250 MG ORAL TWICE DAILY, CEFUROXIME 1.5 G INTRAVENOUSLY (IV) AND VANCOMYCIN 500 MG IV (FREQUENCIES NOT REPORTED). IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE THE OUTCOME FOR THE EVENT OF PATIENT DID NOT WEAR A MASK AND BREAK IN ASEPTIC TECHNIQUE WERE UNKNOWN. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND THE OUTCOME FOR THE EVENT OF PERITONITIS AND FEVER WERE UNKNOWN. THE ROOT CAUSE OF THE PERITONITIS WAS A PATIENT DID NOT WEAR A MASK AND BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF DIANEAL THERAPY CONTINUED. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENTS OF PATIENT DID NOT WEAR A MASK, FEVER AND PERITONITIS.

    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 67 YR Hospitalization| R DIANEAL PD2 1.5% AND 4.25% UNKNOWN BAG