BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2223650 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11255
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT PERFORMED AUTOMATED PERITONEAL DIALYSIS 7 DAYS A WEEK. THE CAUSE OF DEATH WAS REPORTED TO BE COMPLICATION IN HEMODIALYSIS CATHETER IMPLANTATION -CARDIAC TAMPONADE, URGENT CARDIAC SURGERY, AND ANOXIC ENCEPHALOPATHY.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. THE PATIENT LATER DIED OF SURGICAL COMPLICATIONS REPORTED TO BE UNRELATED TO THE PERITONEAL DIALYSIS THERAPY.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A BAXTER HOMECARE NURSE FROM (B)(6) OF PERITONITIS, ABDOMINAL INFECTION AND FATAL POST SURGERY COMPLICATIONS COINCIDENT WITH EXTRANEAL VIAFLEX (IMPORTED FROM THE USA) AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES. IN 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2L PER DAY, IMPORTED FROM (B)(6) USA) AND PHYSIONEAL 35 (1.36%, 15L PER DAY AND 3.86%, 2.5L PER DAY) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY CLOUDY DIALYSATE AND ABDOMINAL PAIN. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLIN (1G PER DAY, IP AND GENTAMYCIN (50MG PER DAY, IP). ON (B)(6) 2011, CEFAZOLIN WAS STOPPED AND CEFTAZIDIME (1.5G PER DAY, IP) AND VANCOMYCIN (1.5G, 3-3 DAYS, IP) WERE ADDED TO THE PATIENT'S REMEDIAL THERAPY. ON (B)(6) 2011, GENTAMICIN WAS STOPPED. ON (B)(6) 2011, THE PERITONITIS RESOLVED AND CEFTAZIDIME AND VANCOMYCIN WERE STOPPED. ON (B)(6) 2011, THE PATIENT AGAIN EXPERIENCED ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT. ON (B)(6) 2011, THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLIN (1G PER DAY, IP) AND GENTAMYCIN (50MG PER DAY). CEFAZOLIN (1G PER DAY, IP) AND GENTAMYCIN WERE STOPPED AND THE PATIENT WAS SWITCHED TO VANCOMYCIN (1.5G, 3-3 DAYS, IP). PER THE REPORTER, THIS PERITONITIS WAS A RECURRENT EPISODE. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED TO UNDERGO PREPARATION FOR CATHETER REPLACEMENT DUE TO THE RECURRENT EPISODES OF PERITONITIS. ON (B)(6) 2011, THE PATIENT RECOVERED FROM THE PERITONITIS AND VANCOMYCIN WAS STOPPED. ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR TENCKHOFF CATHETER REPLACEMENT. IN MID (B)(6) 2011, THE PATIENT DEVELOPED AN ABDOMINAL INFECTION, WHICH PER THE REPORTER ACCORDING TO LABORATORIAL RESULTS WAS NOT PERITONITIS. IN MID (B)(6) 2011, THE PATIENT'S CATHETER WAS REMOVED, EXTRANEAL AND PHYSIONEAL THERAPIES WERE WITHDRAWN AND THE PATIENT BEGAN HEMODIALYSIS. ON (B)(6) 2011, THE PATIENT DIED DUE TO POST SURGERY COMPLICATIONS. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE BELIEVED THE PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA AND (B)(6), RECURRENT PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA AND (B)(6), ABDOMINAL INFECTION AND FATAL POST SURGERY COMPLICATIONS WERE NOT RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES.

    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 48 YR Death| H| R EXTRANEAL VIAFLEX| PHYSIONEAL 35 UNKNOWN BAG