BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1991860 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01980
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    April 1, 2010
    Report Date
    January 22, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PATIENT HAD ANOTHER INCIDENT OF PERITONITIS IN (B)(6), ADDRESSED IN A SEPARATE MEDICAL DEVICE REPORT. 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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. THIS IS A REGULATORY REPORT BY THE (B)(6) HEALTH AUTHORITIES FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR CITROBACTER AND DIFETRIODES IN A COINCIDENT WITH EXTRANEAL VIAFLEX, INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR CITROBACTER AND DIFETRIODES. TREATMENT, HOSPITALIZATION AND OUTCOME WERE NOT REPORTED. THE REPORTING PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 68 YR Other EXTRANEAL VIAFLEX, 2L/DAY (LOT NUMBER UNKNOWN)| LANTUS (INSULIN), NEORECORMON, CARDURA (DOSAZOSIN)| DIDROGYL, LYRICA (PREGABALIN), TRIATEC, RENAGEL| ANTRA, SINVACOR, CARIOASPIRIN, APIDRA (INSULIN)