These cannulae are used to divert large volumes of blood from the heart to the cardiopulmonary bypass machine during cardiac surgery procedures.If not detected prior to use, the bypass machine may alarm for decreased flow.A partial or complete separation will require exchange of the cannula, temporary interruption of bypass, and in a worst case scenario retrieval of the device fragment.Depending on the location of the fracture/separation, it may also result in significant blood loss.The instructions for use (ifu) warns, ¿visually examine the quickdraw venous cannula, introducer(s), and components.Do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open.¿ the subject was not returned for evaluation; therefore, the reported event cannot be confirmed.The root cause of this event cannot be determined at this time.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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D4: udi #(b)(4) h3: evaluation summary: customer report of separated connector from qd cannula was confirmed.As received, the connector end of the cannula was easily separated from main cannula body.No indications of bonding material were found on both the detached connector end and the cannula body end.Cannula was observed to have multiple kinks along the cannula body.No other visual damage, contamination, or other abnormalities were found to the device.H10: additional manufacturer narrative: updated sections d4 (expiration date, udi #), h4.Field corrective action (fca-152) has been initiated for the quickdraw venous cannula separation issue.Review of the device history record (dhr) showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Subsequent investigation and engineering evaluation confirmed a manufacturing defect.Investigation of the root cause is currently under way.H11: corrected data: updated section h7.
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