BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASPAN

    MDR report key: 1311840 · Received February 13, 2009

    Report

    Report Number
    3003568924-2009-00001
    Event Type
    Injury
    Date Received
    February 13, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 21, 2009
    Manufacturer
    BARR LABS
    Product Code
    KDL
    PMA / PMN Number
    K944866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER COULD NOT DETERMINE THE SOURCE OF INFECTION OR DETERMINE IF VIASPAN OR AN ALTERNATE SOURCE CONTRIBUTED TO THE TRANSMISSION OF THE ZYGOMYCETES. WITHOUT A LOT NUMBER OR COMPLAINT SAMPLE FOR THIS COMPLAINT, AN INVESTIGATION INTO THE SPECIFIC CIRCUMSTANCES SURROUNDING THE MANUFACTURE AND TESTING OF THE LOT CANNOT BE CONDUCTED. THE FOLLOWING GENERAL STATEMENTS CAN BE MADE CONCERNING ALL PRODUCT LOTS. VIASPAN IS MANUFACTURED AND PACKAGED BY ANOTHER COUNTRY'S MFR. BARR RECEIVES A CERTIFICATE OF COMPLIANCE AND CERTIFICATE OF ANALYSIS WITH EACH BATCH SENT FROM FRESENIUS KABI. ALL BATCHES ARE MANUFACTURED, PACKAGED, TESTED, AND RELEASED IN ACCORDANCE WITH CGMP, CURRENT APPROVED PROCEDURES, AND ANALYTICAL SPECIFICATIONS. DEVIATIONS, IF ANY, ARE APPROVED AND CLOSED PRIOR TO RELEASE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ZYGOMYCETES INFECTION [ZYGOMYCOSIS]. CASE DESCRIPTION: INFORMATION WAS RECEIVED REGARDING TWO PATIENTS WHO DEVELOPED ZYGOMYCETES INFECTIONS TWO WEEKS AFTER KIDNEY TRANSPLANTS FROM THE SAME DONOR. VIASPAN (BELZER UW) COLD STORAGE SOLUTION WAS USED TO STORE THE KIDNEY, AND BOTH TRANSPLANTS WERE PERFORMED IN THE SAME HOSPITAL. IT WAS REPORTED THAT IT IS UNKNOWN WHETHER VIASPAN OR AN ALTERNATE SOURCE CONTRIBUTED TO THE TRANSMISSION OF THE ZYGOMYCETES. NO ADDITIONAL INFORMATION WAS REPORTED. THIS CASE IS CROSS REFERENCED TO CASE, 3003568924-2009-0002.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening