BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASPAN

    MDR report key: 729372 · Received June 27, 2006

    Report

    Report Number
    3003568924-2006-00002
    Event Type
    Death
    Date Received
    June 27, 2006
    Date of Event
    June 1, 2006
    Report Date
    June 19, 2006
    Manufacturer
    BARR LABS
    Product Code
    KDL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# D5J047100. IN THIS CASE, THREE ORGANS, A LIVER, AND TWO KIDNEYS, WERE HARVESTED FROM ONE DONOR AT HEALTH CENTER USING VIASPAN AS THE PRESERVATION AGENT. THESE THREE ORGANS WERE THEN TRANSPLANTED INTO THREE DIFFERENT RECIPIENTS EACH AT DIFFERENT HOSPITALS. THE CLINICAL STATUS OF THE THREE RECIPIENTS IS AS FOLLOWS: A KIDNEY RECIPIENT BECAME SEPTIC, TESTED POSITIVE FOR CANDIDIASIS AND EXPIRED DUE TO SEPTIC SHOCK. ANOTHER KIDNEY RECIPIENT WAS TREATED PROPHYLACTICALLY WITH ANTIFUNGALS AND IS DOING WELL CLINICALLY. A LIVER RECIPIENT TESTED POSITIVE FOR URINARY CANDIDIASIS AND IS PRESENTLY NOT DOING WELL CLINICALLY. IT IS IMPORTANT TO NOTE THAT THERE ARE MANY POINTS, OTHER THAN THE VIASPAN SOLUTION, IN THIS TRANSPLANTATION PROCESS OF HARVESTING, FLUSHING, PRESERVING, STORING, FLUSHING AND SURGICALLY TRANSPLANTING WHERE THE CONTAMINATION MAY HAVE OCCURRED. ALL PARTIES INVOLVED IN THIS ISSUE ARE UNSURE AS TO WHERE IN THE TRANSPLANTATION PROCESS THE CONTAMINATION OCCURRED. ALL PARTIES ARE CONTINUING TO INVESTIGATE. LASTLY, A REP FROM ORGANIZATION OF TRANSPLANTATION INFORMED BARR THAT HOSPITAL CENTER WAS ALSO TESTING SAMPLES FROM THE TWO LOTS FOR YEAST IN THEIR MICROBIOLOGY LAB. HOSPITAL CENTER STATED THAT THE PRODUCT HAD NO YEAST DETECTED AFTER 48 HOURS AND THAT FURTHER RESULTS WOULD BE AVAILABLE ON JUNE 27, 2006. THE REP FURTHER STATED THAT IT WAS UNKNOWN IF THE VIASPAN SOLUTION WAS CONTAMINATED AFTER OPENING; HOWEVER, THERE WAS NO OBVIOUS BREACH IN PROTOCOL. SHE ADDED THAT THE OTHER TRANSPLANT FACILITIES WERE NOTIFIED OF THE SUSPECTED CONTAMINATED VIASPAN LOT NUMBERS AND WERE ADVISED TO REPLACE THOSE LOTS WITH ANOTHER LOT NUMBER OR USE AN ALTERNATIVE STORAGE SOLUTION, PENDING THE INVESTIGATION. THE RECOMMENDED ADDITIVES (PENICILLIN G, DEXAMETHASONE, INSULIN) WERE NOT KNOWN TO HAVE BEEN ADDED TO FORMULATE THE FINAL SOLUTION OF VIASPAN. IT IS NOT KNOWN IF AN IN LINE PALL BLOOD TRANSFUSION FILTER WAS USED TO FILTER VIASPAN, AS PER THE LABEL. THE NEPHROLOGIST STATED THE CAUSE OF CONTAMINATION IS UNK. CULTURES OF THE SUSPECTED LOTS ARE PENDING.

    Description of Event or Problem · 1

    INFO WAS REC'D REGARDING A KIDNEY TRANSPLANT IN 2006 IN A MALE PT. VIASPAN COLD STORAGE SOLUTION FOR PRESERVATION OF INTRA-ABDOMINAL ORGANS (KIDNEYS, LIVER, AND PANCREAS) WAS USED TO PRESERVE THE KIDNEY ORGAN AFTER HARVESTING FROM A DONOR. AS PER HOSPITAL PROTOCOL, THE SOLUTION CARRYING THE KIDNEY WAS CULTURED. THE CULTURE WAS POSITIVE FOR CANDIDA ALBICANS. THE PT DEVELOPED SEPSIS SECONDARY TO CANDIDA ALBICANS AND SUBSEQUENTLY DIED IN 2006 OF SEPTIC SHOCK. TWO LOTS OF VIASPAN COLD STORAGE SOLUTION ARE SUSPECT FOR CONTAMINATION WITH CANDIDIA ALBICANS: (LOT# D5F217100, EXPIRATION 6/2006 AND LOT# D5J047100, EXPIRATION 10/2006). AT THIS TIME, WE DO NOT KNOW IF THE RECOMMENDED ADDITIVES AND IF THE IN-LINE PALL BLOOD TRANSFUSION FILTER WAS USED. THE NEPHROLOGIST STATED THE CAUSE OF CONTAMINATION IS UNK AND CULTURES OF THE SUSPECTED LOTS OF VIASPAN ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASPAN COLD STORAGE SOLUTION (BELZER UW) KDL BARR LABS UNK D5F217100

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death| O 2. PREDNISONE (PREDNISONE) UNK TO UNK.| 1. IMURAN (AZATHIOPRINE) UNK TO UNK.