BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1812046 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02800
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    June 1, 2009
    Report Date
    August 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHOSE NURSE REPORTED PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. DURING A FOLLOW-UP CALL, ON (B)(6) 2010, THE NURSE PROVIDED THE FOLLOWING INFORMATION. ON (B)(6) 2009, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AFTER AN EFFLUENT CULTURE, OBTAINED THE SAME DAY, (B)(6). THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE NURSE COULD NOT REMEMBER IF THE PATIENT HAD CLOUDY EFFLUENT AT THE TIME OF THE DIAGNOSIS. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (UNSPECIFIED) ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). IN (B)(6) 2009, THE ANTIBIOTIC REGIMEN WAS COMPLETED. ON (B)(6) 2009, A REPEAT EFFLUENT CULTURE SHOWED "NO GROWTH". ON (B)(6) 2009, THE EVENT OF PERITONITIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention CONCOMITANT MEDICATIONS INCLUDED AMARYL, ASPIRIN,