BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961954 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00684
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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 REPORT BY A PHYSICIAN FROM (B)(6) OF EXHAUSTION AND STERILE PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, PHYSIONEAL, UNSPECIFIED PRODUCT AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES (LOT NUMBERS UNKNOWN). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, 2000ML (FREQUENCY AND LOT NUMBER UNKNOWN), PHYSIONEAL, UNSPECIFIED PRODUCT, 2000ML (FREQUENCY AND LOT NUMBER UNKNOWN) AND NUTRINEAL PD4 UNKNOWN BAG, 2000ML (FREQUENCY AND LOT NUMBER UNKNOWN), INTRAPERITONEALLY (IP) FOR DIABETIC NEPHROPATHY. ON (B)(6) 2010, THE PATIENT DEVELOPED STERILE PERITONITIS. THE REPORTING PHYSICIAN EVALUATED THE EVENT OF STERILE PERITONITIS AS CLOUDY EFFLUENT, A LIGHT ABDOMINAL DISCOMFORT AND EXHAUSTION. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT STARTED REMEDIAL TREATMENT WITH FORTUM, 5MG, IP, 2X/DAY AND VANCOMYCIN, 1GM, IP, (FREQUENCY NOT REPORTED). TREATMENT WITH FORTUM ENDED ON (B)(6) 2010 AND TREATMENT WITH VANCOMYCIN REMAINED ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND HAD RECOVERED FROM THE EVENTS OF STERILE PERITONITIS, CLOUDY EFFLUENT AND LIGHT ABDOMINAL DISCOMFORT ON (B)(6) 2010. THE OUTCOME OF THE EVENT OF EXHAUSTION WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2010, EXTRANEAL AND NUTRINEAL WERE DISCONTINUED, HOWEVER PHYSIONEAL REMAINED ONGOING. THE REPORTER BELIEVED THE EVENTS WERE POSSIBLY RELATED TO EXTRANEAL AND NUTRINEAL, BUT UNRELATED TO PHYSIONEAL.

    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 66 YR Hospitalization| R