BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2210474 · Received August 12, 2011

    Report

    Report Number
    1423500-2011-10670
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 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 REPORT WAS RECEIVED FROM BAXTER GLOBAL PHARMACOVIGILANCE (GPV), IS A REPORT BY A BAXTER EMPLOYED NURSE AND A PHYSICIAN FROM (B)(6) OF AUTOMATED PERITONEAL DIALYSIS (APD) NO LONGER SUFFICIENT, PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE, EXIT SITE CULTURE POSITIVE FOR (B)(6) AND FATAL CARDIAC ARREST IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX (IMPORTED FROM USA; LOT NUMBER NOT REPORTED) AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2 L DAILY, LOT NUMBER NOT REPORTED) AND PHYSIONEAL (1.36 % 10 L DAILY AND 2.27 % 5 L DAILY, LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX IMPORTED FROM THE USA. ON AN UNREPORTED DATE, APD WAS NO LONGER SUFFICIENT FOR THE PATIENT. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, EXTRANEAL VIAFLEX AND PHYSIONEAL 2.27% WERE WITHDRAWN. THE DOSE OF PHYSIONEAL 1.36% WAS REDUCED. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH CEFTAZIDIME (1G/DAY, IP) AND VANCOMYCIN (2G, 3-3 DAYS, IP), DURING NIGHT CYCLE (6-8 HOURS PERMANENCE WITH PHYSIONEAL 1. 36%). ON (B)(6) 2011, THE PATIENT BEGAN HEMODIALYSIS. PER THE PHYSICIAN, THE TRANSITION WAS PROGRAMMED PRIOR TO HOSPITALIZATION, BECAUSE APD WAS NO LONGER SUFFICIENT. THE PERITONITIS WAS RESOLVING. ON (B)(6) 2011, DURING THE PATIENT'S THIRD HEMODIALYSIS SESSION, THE PATIENT DIED DUE TO A SUDDEN CARDIAC ARREST. IT WAS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. PHYSIONEAL 1.36% WAS REPORTED AS WITHDRAWN ON (B)(6) 2011. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PHYSICIAN BELIEVED THE EVENTS OF AUTOMATED PERITONEAL DIALYSIS (APD) NO LONGER SUFFICIENT, PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE, EXIT SITE CULTURE POSITIVE FOR (B)(6) AND FATAL CARDIAC ARREST WERE NOT RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES. NO FURTHER INFORMATION IS AVAILABLE.

    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 49 YR Hospitalization| R PHYSIONEAL| HOMECHOICE| EXTRANEAL VIAFLEX