BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1801963 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02556
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE PRODUCT'S LABELING WAS PERFORMED: THE CURRENT LABELING PROVIDES A WARNING THAT STATES 'USE ASEPTIC TECHNIQUE'. THE WARNING ALSO STATES 'CONTAMINATION OF ANY PORTION OF THE FLUID PATH MAY RESULT IN PERITONITIS'. THE CURRENT LABELING FOR THE COMPACT EXCHANGE DEVICE II WAS FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. THIS REPORT IS RELATED TO THE PERITONITIS EVENT IN REPORT NUMBERS: 1423500-2010-02549, 1423500-2010-02552, AND 1423500-2010-02554.

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A CALL FOR AN UNRELATED LOW DRAIN VOLUME ALARM, THE HOME PATIENT INDICATED HIS EFFLUENT WAS CLOUDY AND WAS BLOOD-TINGED. THE FOLLOWING INFORMATION WAS OBTAINED FROM GLOBAL PHARMACOVIGILANCE ON 07/23/2010: THE PATIENT'S NURSE INDICATED THE PATIENT STARTED PERITONEAL DIALYSIS (PD) THERAPY A COUPLE OF YEARS AGO (EXACT DATE UNKNOWN) WITH DIANEAL PD4 AMBUFLEX (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEAL (IP) FOR PD. ON AN UNKNOWN DATE IN 2010, THE PATIENT EXPERIENCED CLOUDY AND BLOOD TINGED EFFLUENT AND WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN 2010, AN EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE ANALYSIS REVEALED AN ELEVATED LEUCOCYTE COUNT AND THE CULTURE REVEALED STAPHYLOCOCCUS. ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS, IP. THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON UNREPORTED DATES IN 2010, THE PATIENT COMPLETED ANTIBIOTIC THERAPY AND THE PERITONITIS AND BLOOD TINGED EFFLUENT RESOLVED. DIANEAL THERAPY WAS ONGOING, DOSE UNCHANGED. MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD). THE PATIENT WAS TAKING UNSPECIFIED CONCOMITANT MEDICATIONS. IT WAS UNKNOWN TO THE NURSE IF THE PERITONITIS AND BLOOD TINGED EFFLUENT WERE RELATED TO DIANEAL THERAPY. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING LOT NUMBERS WERE DELIVERED TO THE HOME PATIENT IN 2010 SO FAR (AS THE DATE OF DIAGNOSIS IS UNKNOWN): HOMECHOICE CASSETTE (PRODUCT CODE 5C4531C) (B)(6): LOT H09K12012, (B)(6): LOT H09L06509, (B)(6): LOT H10A26092, (B)(6): LOT H10B11027, (B)(6), LOT H10C27013, (B)(6): LOT H10D27037, (B)(6): H10E21045. MINICAP DISCONNECT CAP (PRODUCT CODE 5C4466P) (B)(6): LOT GD870949, (B)(6): LOT GD873919. TRANSFER SET- DELIVERED TO THE PATIENT'S CLINIC (PRODUCT CODE 5C4482) (B)(6) 2010: H10B01028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DIANEAL PD4 AMBUFLEX