BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2121613 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07515
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN; THEREFORE, D4 IS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE EVENT OF PERITONITIS ASSOCIATED TO CAPD RESOLVED. DIANEAL, EXTRANEAL AND NUTRINEAL THERAPIES WERE ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE: ON (B)(6) 2011, THE SUBJECT WAS REHOSPITALIZED FOR RESPIRATORY ARREST PERITONITIS ASSOCIATED TO CAPD. THE SUBJECT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). THE PERITONEAL EFFLUENT WAS TURBID. ON (B)(6) 2011, THE SUBJECT RECEIVED VANCOMYCIN (1 GM IV EVERY 5 DAYS). ON (B)(6) 2011, THE SUBJECT BEGAN PIPERACILLIN/TAZOBACTAN (2.25 G IV EVERY 8 HOURS). ON (B)(6) 2011, PIPERACILLIN/TAZOBACTAN WAS DISCONTINUED, AND THE SUBJECT BEGAN MEROPENEM (1 G, IV EVERY 12 HOURS). REMEDIAL THERAPY WITH VANCOMYCIN AND MEROPENEM WERE ONGOING, BUT WITHOUT IMPROVEMENT. THE RESPIRATORY ARREST RESOLVED ON (B)(6) 2011. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. STUDY TITLE: MULTI-CENTER, PROSPECTIVE, RANDOMIZED TRIAL TO DEMONSTRATE IMPROVED METABOLIC CONTROL OF DIANEAL, EXTRANEAL, NUTRINEAL (D-E-N) VS DIANEAL ONLY IN THE TREATMENT OF DIABETIC CAPD PATIENTS. THIS IS A CLINICAL REPORT BY A PHYSICIAN FROM COLOMBIA OF PERITONITIS ASSOCIATED TO PERITONEAL DIALYSIS IN A (B)(6) MALE HISPANIC SUBJECT COINCIDENT WITH DIANEAL, EXTRANEAL VIAFLEX, AND NUTRINEAL PD4 THERAPIES. ON AN UNREPORTED DATE, THE SUBJECT BEGAN DIANEAL, EXTRANEAL VIAFLEX, AND NUTRINEAL PD4 THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE SUBJECT WAS HOSPITALIZED DUE TO PERITONITIS ASSOCIATED TO PERITONEAL DIALYSIS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, ULTRAFILTRATION FAILURE, AND ASSOCIATED DYSPNEA. DUE TO PULMONARY EDEMA, THE SUBJECT WAS SENT TO THE INTENSIVE CARE UNIT. DIALYSIS WITH HIGH CONCENTRATION PRODUCTS WAS STARTED. ON (B)(6) 2011, THE SUBJECT BEGAN TREATMENT WITH INTRAPERITONEAL VANCOMYCIN (2G AMP DAILY) TO TREAT THE PERITONITIS. ON (B)(6) 2011, THE SUBJECT BEGAN TREATMENT WITH INTRAVENOUS PIPERACILLIN/TAZOBACTAM (4.5 G AMP EVERY 12 HOURS). IT WAS NOT REPORTED WHETHER DIANEAL, EXTRANEAL VIAFLEX, OR NUTRINEAL PD4 THERAPIES WERE ONGOING. ON (B)(6) 2011, TREATMENT WITH PIPERACILLIN/TAZOBACTAM WAS DISCONTINUED. TREATMENT WITH VANCOMYCIN WAS ONGOING. THE PERITONITIS WAS RESOLVING, AS EVIDENCED BY IMPROVEMENT IN THE APPEARANCE OF THE LIQUID AND IMPROVEMENT IN THE ULTRAFILTRATION. THE INVESTIGATOR DEEMED THE PERITONITIS ASSOCIATED TO PERITONEAL DIALYSIS MODERATE IN SEVERITY AND NOT ASSOCIATED TO DIANEAL, EXTRANEAL VIAFLEX, AND NUTRINEAL PD4 THERAPIES OR THE TRIAL PROCEDURE. PULMONARY EDEMA WAS PROVIDED AS AN ALTERNATIVE ETIOLOGY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R CALCITRIOL| CLONIDINE| ERYTHROPOIETIN| B COMPLEX| CALCIUM CARBONATE