BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2110642 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06932
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE INVESTIGATOR. THE ADVERSE EVENT OF PERITONITIS WAS AMENDED TO PERITONITIS CAUSED BY CAPD. IT WAS CLARIFIED THAT THE LAST DOSE OF INVESTIGATIONAL THERAPY PRIOR TO THE ONSET OF THE EVENT WAS ON (B)(6) 2011, AT 20:00 FOR A DURATION OF 10 HOURS (4 TIMES PER DAY, IP, LOT NUMBER SB11CD8). ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE SUBJECT'S PERITONEAL EFFLUENT WAS COMPLETELY CLEAR. THE SUBJECT WAS ASYMPTOMATIC, EATING AND SLEEPING WELL, AND HIS BLOOD PRESSURE WAS CONTROLLED. ON (B)(6) 2011, REMEDIAL THERAPY WITH ERTAPENEM WAS DISCONTINUED, AND THE EVENT WAS CONSIDERED RESOLVED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS REPORTED BY A PHYSICIAN THE PATIENT TOOK PART IN THE FOLLOWING STUDY: (B)(4). THE (B)(4) STUDY, SPONSORED BY (B)(4). THE INVESTIGATOR CONSIDERED THE EVENT OF PERITONITIS TO BE UNRELATED TO INVESTIGATIONAL PRODUCT AND TRIAL PROCEDURE. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A CLINICAL REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A (B)(6) PATIENT COINCIDENT WITH DIANEAL PD2 THERAPY. ON AN UNREPORTED DATE, THE SUBJECT BEGAN TREATMENT WITH DIANEAL PD2 (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011 AT 0800, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN AND LOOSE STOOLS. ON (B)(6) 2011, THE SUBJECT WAS DIAGNOSED WITH PERITONITIS AND RECEIVED TREATMENT WITH CEPHRADINE 1 GM IP ONCE PER DAY AND AMIKACIN 100 MG IP ONCE PER DAY FOR ANTIBIOTIC THERAPY. THE SUBJECT ALSO RECEIVED TREATMENT WITH A SINGLE DOSE OF METOCLOPRAMIDE 10 MG INTRAVENOUSLY (IV) FOR ANTIEMETIC THERAPY AND HYOSCINE BUTYLBROMIDE 1 AMPULE IV FOR ANALGESIC THERAPY. ON (B)(6) 2011, THE SUBJECT RECEIVED DIANEAL PD2 (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) IP FOR CAPD. ON (B)(6) 2011, THE PERITONEAL FLUID REMAINED CLOUDY AND THE SUBJECT CONTINUED TO EXPERIENCE ABDOMINAL PAIN AND LOOSE STOOLS. ON THE SAME DAY, DUE TO INADEQUATE RESPONSE, THE SUBJECT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WITH CEPHRADINE AND AMIKACIN WAS DISCONTINUED. ON (B)(6) 2011, THE SUBJECT RECEIVED TREATMENT WITH ERTAPENEM 500 MG DAILY FOR 14 DAYS FOR ANTIBIOTIC THERAPY. THE SUBJECT WAS NOT RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY WAS CONTINUED AT THE SAME DOSE AND FREQUENCY. THE INVESTIGATOR CONSIDERED THE PERITONITIS TO BE SEVERE. THE INVESTIGATOR PROVIDED THE ALTERNATIVE ETIOLOGY OF INFECTION FOR THE PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R BISACODYL| ACETAMINOPHEN| METOPROLOL| LOSARTAN| NIFEDIPINE| INSULIN NPH| CLONIDINE| ERYTHROPOIETIN| GEMFIBROZIL| DIANEAL PD2| ACETYLSALICYLIC ACID