BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2853466 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06283
    Event Type
    Death
    Date Received
    November 30, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. 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 CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS CONFIRMED. THE ROOT CAUSE FOR THE REPORT OF USE ERROR-BREACH IN ASEPTIC TECHNIQUE, WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE USE ERROR IN THIS REPORT.

    Description of Event or Problem · 1

    THIS REPORT CAME FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A REGISTERED NURSE (RN) IN THE USA OF DEATH IN A HOMECHOICE HOME PATIENT (HP). THE RN REPORTED THAT THE HP HAD PASSED AWAY ON (B)(6) 2012. THE CAUSE OF DEATH WAS SEPSIS. THE CAUSE OF THE SEPSIS WAS NOT REPORTED. THE RN STATED THAT SHE BELIEVED THAT PD THERAPY MAY HAVE BEEN A PARTIAL CAUSE IN THE HP'S DEATH AS THE CATHETER HAD REQUIRED BEING REMOVED AND THE HP HAD BEEN SWITCHED TO HEMODIALYSIS. FURTHER INFORMATION WAS RECEIVED FROM GPV WITH ADDITIONAL INFORMATION FROM THE RN. GPV FOLLOWED UP WITH THE RN ON (B)(6) 2012 AND THE RN REPORTED THAT ON OR AROUND (B)(6) 2012 THE HP EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A TOUCH CONTAMINATION. THE HP WAS HOSPITALIZED FOR THE EVENT ON (B)(6) 2012. THE HP WAS TREATED WITH VANCOMYCIN INTRA-PERITONEALLY (IP) (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2012 THE PD CATHETER WAS REMOVED AND THE HP WAS SWITCHED TO HEMODIALYSIS. THE HP REMAINED HOSPITALIZED UNTIL DEATH. THE HP WAS NOT RETRAINED ON PROPER ASEPTIC TECHNIQUE DUE TO THE HOSPITALIZATION AND DISCONTINUATION OF PD THERAPY. THE RN STATED THAT THE HP PASSED AWAY ON (B)(6) 2012. THE CAUSE OF DEATH WAS SEPSIS. IT WAS UNKNOWN IF AN AUTOPSY WAS DONE. THE RN STATED THAT THE EVENTS WERE NOT RELATED TO DIANEAL THERAPY.

    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 76 YR Death| H| R HOMECHOICE| DIANEAL LOW CA 1.5%| DIANEAL LOW CA 2.5%