BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1974907 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01326
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 9, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED AT THIS TIME. 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING DATA WAS INADVERTENTLY LEFT OUT OF THE ORIGINAL REPORT: ON (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH BIEFFE FORMULAE 55 FOUR TIMES A DAY (DOSE AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT ALSO EXPERIENCED FEVER. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND BEGAN TREATMENT WITH CEFAZOLIN 250 MG FOUR TIMES PER DAY AND CEFTAZIDIME 250 MG FOUR TIMES PER DAY. ON (B)(6) 2011, TREATMENT WITH CEFAZOLIN WAS DISCONTINUED AND THE PATIENT BEGAN TREATMENT WITH CIPROFLOXACIN 180 MG TWICE PER DAY. FROM (B)(6) 2011, THE PATIENT RECEIVED HYPERTONIC SALINE AT 3 ML/HR EVERY 24 HOURS FOR HYPERNATREMIA AND POTASSIUM CHLORIDE THREE TIMES PER DAY FOR HYPOKALEMIA, WHICH THE NURSE CONSIDERED NORMAL FOR PATIENTS WITH END STAGE RENAL DISEASE (ESRD). THE PATIENT WAS RECOVERING FROM THE BACTERIAL PERITONITIS. OUTCOME FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND FEVER WERE NOT REPORTED. BIEFFE THERAPY WAS CONTINUED AT THE SAME DOSE. THE NURSE BELIEVED THE EVENT OF BACTERIAL PERITONITIS WAS UNRELATED TO BIEFFE THERAPY. THE NURSE STATED THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND FEVER IN RELATION TO BIEFFE THERAPY.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) ((B)(4)) OF PERITONITIS BACTERIAL IN A (B)(6)FEMALE PATIENT COINCIDENT WITH CLEARFLEX PD4 1.36% GLUCOSE THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R