BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3180519 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16014
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    October 1, 2012
    Report Date
    May 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT THAT ACQUIRED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. ON AN UNREPORTED DATE, PATIENT'S PAIN IN HER LEGS WAS REPORTED TO BE SO BAD THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THEY SAID THERE WAS NO CIRCULATION IN BOTH HER LEGS. AN ANGIOPLASTY WAS PERFORMED IN BOTH LEGS (FROM THE GROIN AREA TO THE HEART) TO CLEAN OUT HER ARTERIES WHICH WERE CLOGGED. THE PATIENT WAS PLACED IN A REHAB FACILITY AFTERWARDS FOR THREE AND A HALF MONTHS. THE PATIENT RETURNED HOME AND WAS RETURNED BACK TO THE REHAB FACILITY A MONTH LATER. ON AN UNREPORTED DATE, THE PATIENT WAS AGAIN IN A LOT OF PAIN IN HER LEFT LEG BECAUSE SHE DID NOT TAKE HER INSULIN PROPERLY. LATER THE PATIENT BECAME COMBATIVE, WAS NOT TAKING HER MEDICATIONS AND WAS NOT COHERENT (ONSET DATE NOT REPORTED). ON AN UNREPORTED DATE, IT WAS DECIDED TO AMPUTATE HER LEFT LEG ABOVE KNEE. TWO WEEKS LATER ON AN UNREPORTED DATE, PATIENT WAS BACK AT THE REHAB CENTER. ON AN UNREPORTED DATE, THE PATIENT GOT PERITONITIS IN THE HOSPITAL. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS. THE PATIENT WAS THEN SENT BACK TO REHAB WHERE THEY CONTINUED WITH UNKNOWN ANTIBIOTICS FOR A WEEK. THE DOCTOR CALLED AND SAID THAT THE PATIENT WAS DIAGNOSED WITH RECURRENT PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS UNCOMFORTABLE AND WAS DISCONNECTED FROM HER DIALYSIS. ON AN UNREPORTED DATE, IT WAS FOUND THAT THE PATIENT WAS NOT BREATHING. THE FACILITY CALLED THE PARAMEDICS AND TRIED CARDIOPULMONARY RESUSCITATION (CPR) BUT WAS UNSUCCESSFUL. AN AUTOPSY WAS PERFORMED THE FOLLOWING WEEK AFTER HER DEATH. INITIAL VERBAL REPORT SAID THAT THE PATIENT DID NOT HAVE PERITONITIS (NO SIGN OF PERITONITIS). MOST LIKELY PATIENT DIED FROM HEART FAILURE OR HEART ATTACK DUE TO FLUID. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280063 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL PD4 1.5%| INSULIN| EXTRANEAL 7.5%