BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961938 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00655
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    November 1, 2009
    Report Date
    December 20, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    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 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS MITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS "MOST PROBABLY HE TOUCHED THE CONNECTIONS." ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH AZACTAM 1 DAILY (UNTIL (B)(6) 2010) AND VANCOMYCIN 1 GRAM DAILY (UNTIL (B)(6) 2010). ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS. THE OUTCOME FOR THE BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. EXTRANEAL CONTINUED AND THE ACTION TAKEN WITH NUTRINEAL WAS NOT REPORTED. THE PHYSICIAN CONSIDERED THE BACTERIAL PERITONITIS UNRELATED TO EXTRANEAL AND DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR NUTRINEAL. A CAUSALITY ASSESSMENT WAS NOT PROVIDED FOR THE BREAK IN ASEPTIC TECHNIQUE. FOLLOW-UP INFORMATION WAS RECEIVED FROM A PHYSICIAN ON (B)(4) 2010. SUSPECT PRODUCT WAS CLARIFIED AS EXTRANEAL (NUTRINEAL WAS OMITTED AS A SUSPECT PRODUCT). REPORTEDLY, ON (B)(6) 2010, EXTRANEAL WAS DISCONTINUED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE EVENT OF BACTERIAL PERITONITIS.

    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 85 YR Hospitalization| R KALIUM (POTASSIUM)| LOPRESS| SIMVASTATIN| ISMO| IMOVANE| SELOKEN ZOC| OMEPRAZOLE| HJERTAMAGNYL| ETALPHA| EXTRANEAL (CODE AND LOT UNKNOWN)| NORVASC (AMLODIPINE)| MIMPARA| STESOLID| ATARAX-P