BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIASPAN

    MDR report key: 909491 · Received September 10, 2007

    Report

    Report Number
    3003568924-2007-00001
    Event Type
    Other
    Date Received
    September 10, 2007
    Report Date
    September 4, 2007
    Manufacturer
    BARR LABS
    Product Code
    KDL
    PMA / PMN Number
    K944866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT OF ONE LEAKING BAG OF VIASPAN WITH AIR POCKET/BUBBLE AND 20 BAGS WITH AIR POCKETS/BUBBLES GREATER IN SIZE THAN PREVIOUSLY OBSERVED FROM OTHER MANUFACTURED BATCHES. AN INVESTIGATION REPORT REGARDING GAS BUBBLES IN VIASPAN BAGS WAS RECEIVED FROM THE MFR, IN 2007. THE REPORT STATES THE STABILITY DATA OF BATCHES PRODUCED AT FACILITY SHOW EVIDENCE THAT A LARGE GAS BUBBLE (MORE THAN 4 CM IN DIAMETER) DOES NOT JEOPARDIZE THE PRODUCT QUALITY OF VIASPAN. THE INVESTIGATION SUMMARY STATES THE GAS BUBBLE SHOULD HAVE NO ADVERSE EFFECT IF CORRECTLY ADMINISTERED ACCORDING TO THE PACKAGE INSERT LEAFLET. IT WAS ALSO REPORTED IN THE INVESTIGATION SUMMARY THAT A GAS BUBBLE WITH MORE THAN 4 CM IN DIAMETER HAS NO INFLUENCE ON THE PRODUCT QUALITY OR FLUSHED ORGANS. THE COMPLAINT SAMPLE IS IN TRANSIT TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

    PRODUCT COMPLAINT [COULD NOT BE CODED]. CASE DESCRIPTION: INFORMATION WAS RECEIVED FROM A PERFUSIONIST REGARDING 21 BAGS OF VIASPAN SOLUTION. IT WAS REPORTED THAT THEY RECEIVED 20 BAGS FROM LOT NUMBER H050023 EXP 05/31/2008, THAT CONTAINED AIR POCKETS APPROX 20 CC LARGE. IN ADDITION, BETWEEN THE INNER AND OUTER BAGS THERE WERE SPOTS OF MOISTURE. IT WAS REPORTED THAT ONE BAG FROM LOT NUMBER H060026 EXP 06/2008, CONTAINED AN AIR POCKET APPROX 20 CC LARGE, AND CONTAINED APPROX ONE TEASPOON OF LIQUID BETWEEN THE INNER AND OUTER BAGS. UPON VISUAL INSPECTION OF THE BAGS AT THE DISTRIBUTION CENTER ON 09/04/2007, IT WAS NOTED THE AIR POCKETS WERE APPROX 5CM IN DIAMETER AND THERE WAS NO CONDENSATION PRESENT BETWEEN THE INNER AND OUTER BAGS FROM LOT NUMBER H060026. THE DATE OF MFR FOR THE TWO SUSPECT LOTS WERE AS FOLLOWS: LOT NO. H050023 - DATE OF MFR - 05/18/2007. LOT NO. H060026 - DATE OF MFR - 06/15/2007. WITH REGARDS TO LEAKING BAG, INVESTIGATION SUMMARY IS PENDING AND WILL BE FORWARDED WHEN RECEIVED FROM THE MFR. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE REPORTED EVENT IS AN UNLABELED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASPAN COLD STORAGE SOLUTION (BELZER UW) KDL BARR LABS UNK H050023

    Patients

    Seq Age Sex Outcome Treatment
    1 YR