BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCA

    MDR report key: 428476 · Received November 12, 2002

    Report

    Report Number
    MW1026744
    Event Type
    Death
    Date Received
    November 12, 2002
    Date of Event
    June 12, 2002
    Report Date
    November 12, 2002
    Manufacturer
    VASCA, INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT DIED OF COMPLICATIONS FROM AN INFECTION WHICH RPTR WAS LED TO BELIEVE WAS CAUSED BY IMPLANTATION OF A LIFE SITE DIALYSIS ACCESS SYSTEM. PT WS PLACED ON DIALYSIS DURING A HOSPITAL VISIT IN EARLY MAY, 2002. PT WAS HOSPITALIZED AGAIN WITH BREATHING AND BLOOD PRESSURE PROBLEMS WHICH WORSENED TO THE POINT THAT THEY WERE PLACED ON A VENTILATOR AND BLOOD PRESSURE HAD TO BE MAINTAINED. RPTR WAS INFORMED BY DOCTORS THAT PT HAD A SEPTIC INFECTION CAUSED BY THE LIFESITE. THE LIFESITE DEVICE WAS REMOVED BUT PT WAS UNABLE TO RECOVER AND THEY DIED. RPTR HAD NOT THOUGHT ANYTHING ABOUT IT, UNTIL THEY RECEIVED A LETTER FROM PT'S PHYSICIAN NOTIFYING THEM THAT A CLASS ACTION LAWSUIT WAS DROPPED RELATED TO THIS DEVICE. WHEN RPTR REVIEWED THE FDA WEBSITE FOR THE HISTORY ON THIS DEVICE, THEY LEARNED THAT IT WAS FAULTED NWE-04-02W IN NOVEMBER 2001 THAT THE DEVICE WAS NOT BEING PROPERLY LABELED AND USED. THE LETTER INDICATED THAT THE DEVICE WAS TO BE USED FOR PATIENTS AWAITING A PERMANENT ACCESS DEVICE, BUT THIS WAS NEVER DISCUSSED WITH RPTR OR WITH PT THAT THEY ARE AWARE. PT WAS TOLD THAT THIS WAS A NEW DEVICE WHICH HAD BEEN SHOWN TO REDUCE INFECTIONS THAT WERE COMMON WITH OTHER CATHETERS. TO RPTR'S KNOWLEDGE THERE WERE NO PLANS TO REPLACE IT. PT ALSO SUFFERED FROM BLEEDING AROUND AND UNDER THE SKIN WHERE THE DEVICE WAS IMPLANTED. RPTR ALSO SUSPECTS THAT THE NURSING HOME STAFF WASN'T PROPERLY PREPARED FOR THE CARE OF THIS DEVICE, BUT DID NOT CONCERN THEMSELVES BECAUSE PT WAS GOING TO A DIALYSIS CENTER EVERY OTHER DAY. RPTR REALIZES THAT PT WAS ELDERLY AND THEIR KIDNEYS WERE FAILING, BUT THEIR FINAL WEEK OF LIFE WAS A MISERABLE, PAINFUL TRAUMA ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCA LIFESITE DIALYSIS ACCESS SYSTEM MSD VASCA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death