BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2914436 · Received January 14, 2013

    Report

    Report Number
    1416980-2013-00995
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    July 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, FURTHER INFORMATION WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE (GPV) FROM A HEALTH CARE PROFESSIONAL WHO MEDICALLY CONFIRMED THE REPORT. ON AN UNREPORTED DATE, DIANEAL, EXTRANEAL AND INTERLINEAL THERAPIES WERE WITHDRAWN AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A 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 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. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS, CANCER, PERFORATED STOMACH, BLEEDING, INFECTION, MASS WAS GROWING IN THE STOMACH, AND COMA IN A PATIENT COINCIDENT WITH DIANEAL PD4 1.5% AND 2.5%, EXTRANEAL 7.5%, AND NUTRINEAL 1.1% THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER (B)(4) CUSTOMER CARE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED CANCER. THE PATIENT WAS HOSPITALIZED FOR AN UNSPECIFIED PLANNED SURGERY FOR CANCER WHEN THEIR STOMACH WAS PERFORATED (DUE TO QUICKLY TRYING TO STEM THE BLEEDING). THE PATIENT DEVELOPED AN INFECTION AND A MASS WAS GROWING IN THE STOMACH. THE BODY RECOGNIZED THE CATHETER AS SOMETHING FOREIGN AND ATTACKED IT, SO THE PATIENT WAS PUT INTO A 2 WEEK COMA. ON (B)(6) 2012, THE PATIENT HAD PROLONGED HOSPITALIZATION FOR PERFORATED STOMACH, BLEEDING, INFECTION, AND COMA. THE PATIENT WAS NOW ON 24 HOUR OXYGEN. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE COMA. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE EVENTS OF PERITONITIS, CANCER, PERFORATED STOMACH, BLEEDING, INFECTION, AND MASS WAS GROWING IN THE STOMACH. ON AN UNREPORTED DATE, THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19806 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD4 1.5%| EXTRANEAL 7.5%| DIANEAL PD4 2.5%| NUTRINEAL 1.1%