BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1842416 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03641
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICES INVOLVED IN THE INCIDENT WERE 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 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS. ON (B)(6) 2006, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON (B)(6) 2010, PRIOR TO ANTIBIOTIC THERAPY, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE CULTURE RESULT SHOWED "NO GROWTH". ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH (UNSPECIFIED) ANTIBIOTICS. THE EVENT OF PERITONITIS WAS ONGOING AND IMPROVED. PD THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY. THE ROOT CAUSE OF THE PERITONITIS WAS DUE TO A RELAPSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 UNKNOWN BAG