BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRL TUBE, 1/4X1/16 X 6'

    MDR report key: 2222355 · Received August 18, 2011

    Report

    Report Number
    1718850-2011-00097
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT OF A BRIGHT GREEN DISCOLORATION NOTED ON THE TUBING AFTER A COUPLE OF DAYS ECMO. THERE WAS NO PATIENT IMPACT. COMMUNICATION WITH THE CUSTOMER LATER INDICATED THAT THE FACILITY FELT THE GREEN SPOTS MAY BE A BACTERIAL GROWTH AND THE PATIENT'S BLOOD WAS CULTURED. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. THE FACILITY HAS SINCE REPORTED THAT NO BACTERIAL GROWTH WAS FOUND. ONE PIECE OF 1/4" TUBING WAS RETURNED TO SGU FOR EVALUATION. UPON RECEIPT, THE TUBING WAS SUBJECTED TO VISUAL INSPECTION. VISUAL INSPECTION CONFIRMED THE PRESENCE OF SPOTS ON THE TUBING. THE COMPOSITION AND ORIGIN OF THE SPOTS COULD NOT BE DETERMINED. THE SAMPLE WAS SENT TO AN OUTSIDE LABORATORY FOR ANALYSIS. THE LABORATORY HAS COMPLETED THEIR ANALYSIS. VISUAL INSPECTION OF THE TUBING CROSS-SECTION INDICATES THAT THE STAINING IS ON THE EXTERIOR DIAMETER OF THE TUBING. THEREFORE, THERE WOULD BE NO PATIENT CONTACT. THE FTIR SPECTRA OF THE TUBING IN THE STAINED AREA AND THE NON-STAINED AREA ARE CONSISTENT WITH EACH OTHER, AND BOTH ARE CONSISTENT WITH A LIBRARY SPECTRUM OF PVC. THERE ARE NO FEATURES IN THE SPECTRUM OF THE STAINED AREA THAT WOULD SUGGEST AN ADDITIONAL COMPONENT IS PRESENT IN THE MATERIAL. THE REPORT STATED THAT IT IS POSSIBLE THAT THE STAINING IS SOME FORM OF DYE, AND THAT THERE IS AN INSUFFICIENT AMOUNT OF THE DYE PRESENT TO PRODUCE TO PRODUCE A RESPONSE IN THE FTIR ANALYSIS. THIS PRODUCT WAS SOLD AND SHIPPED TO THE CUSTOMER BY GISH BIOMEDICAL. IN JULY 2010, SORIN GROUP USA ACQUIRED GISH BIOMEDICAL. GISH MANUFACTURING OPERATIONS HAVE BEEN DISCONTINUED. MANUFACTURING PERSONNEL ARE NO LONGER AVAILABLE. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT OF A BRIGHT GREEN DISCOLORATION NOTED ON THE TUBING AFTER A COUPLE DAYS OF ECMO. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRL TUBE, 1/4X1/16 X 6' CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1