BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1802185 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02567
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 28, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENTS DISCARD THE SAMPLES AFTER EACH THERAPY, THEREFORE NO SAMPLE WAS RETURNED FOR EVALUATION. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A HEALTHCARE PROFESSIONAL VIA SALES REPRESENTATIVE FROM (B)(6) OF PERITONITIS AND DEATH IN A (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, INTRAPERITONEALLY (IP), FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH AN UNSPECIFIED 1.36% GLUCOSE SOLUTION, INTRAPERITONEALLY (IP), FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, EXTRANEAL AND THE UNSPECIFIED 1.36% GLUCOSE SOLUTION WERE DISCONTINUED. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH IP MEDICATIONS OF CEFUROXIME, 1500MG AND GENTAMYCIN 80MG. THE PATIENT WAS ALSO TREATED BY PERFORMING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) WITH AN UNSPECIFIED 1.36% GLUCOSE SOLUTION. WHILE ON CAPD, THE PERITONEAL EFFLUENT WAS RUNNING IN AT APPROXIMATELY 500ML, THE PATIENT HAD DEVELOPED ABDOMINAL PAIN AND CAPD WAS STOPPED. DURING THE NIGHT ON (B)(6) 2010, THE PATIENT DIED WHILE HOSPITALIZED. THE CAUSE OF DEATH WAS UNSPECIFIED. IT WAS UNREPORTED WHETHER AN AUTOPSY WAS PERFORMED AND THE AUTOPSY REPORT WAS NOT AVAILABLE. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THE UNSPECIFIED 1.36% GLUCOSE SOLUTION AS SUSPECT, AS WELL AS TREATMENT. OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT RESOLVED PRIOR TO DEATH. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE HEALTHCARE PROFESSIONAL REPORTED THE EVENTS WERE NOT RELATED TO EXTRANEAL THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE INTRODUCER WAS LEFT IN THE ROTATING HEMOSTATIC VALVE DURING THE CASE. DURING REMOVAL OF THE GUIDE WIRE, THE GREEN COATING WAS NOTED TO BE FLAKING OFF AT THE VERY PROXIMAL PART OF THE GUIDE WIRE, OUTSIDE THE PATIENT'S BODY. THE PORTION OF THE GUIDE WIRE THAT WAS INSIDE THE PATIENT WAS NOT NOTED TO BE FLAKING. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS KDJ UNKNOWN MANUFACTURING FACILITY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention THE PATIENT BEGAN TREATMENT WITH EXT