BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1880609 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04834
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 1, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 MDR 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NEPHROLOGIST WITH SUPPLEMENTAL INFORMATION PROVIDED BY A SECOND PHYSICIAN FROM (B)(6) OF ASEPTIC PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH NUTRINEAL PD4 UNKNOWN BAG. ON (B)(6) 2010 THE PATIENT EXPERIENCED CLOUDY EFFLUENT, WITHOUT CLINICAL SIGNS, AND WAS DIAGNOSED WITH ASEPTIC PERITONITIS. IT WAS NOTED THAT NO TREATMENT WAS ADDED TO THE PERITONEAL SOLUTION, THE PATIENT DID NOT MIX THE PERITONEAL SOLUTIONS TOGETHER AND NO SOLUTION WAS HEATED. THE EXIT SITE WAS NOT INFECTED, AND THE PATIENT DID NOT ROUTINELY RE-USE SUPPLIES. IN (B)(6) 2010, CORRECTIVE TREATMENT CONSISTED OF CEFAZOLINE 1G DAILY (ROUTE NOT REPORTED) AND FORTUM (CEFTAZIDIME) 2G DAILY (ROUTE NOT REPORTED). ON AN UNSPECIFIED DATE IN (B)(6) 2010, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. ON (B)(6) 2010, THE PATIENT USED A NEW LOT OF NUTRINEAL FOR THE FIRST TIME WITHOUT A REPORTED TOLERANCE PROBLEM. THE REPORTERS BELIEVED THAT THE EVENT OF ASEPTIC PERITONITIS WAS PROBABLY RELATED TO NUTRINEAL THERAPY.

    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 70 YR Required Intervention PLAVIX, KARDEGIC, CARDENSIEL, FLODIL, LANTUS| NOVORAPID, RENAGE, CALCIDIA, ARANESP| EXTRANEAL VIAFLEX, PHYSIONEAL 40, GLIVEC, LASILIX