EDWARDS LIFESCIENCES THIN-FLEX VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number TF022O90 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional investigation is underway.Additional information will be provided in a supplemental report.
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Event Description
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As reported the tip of a 22fr venous cannula was not as stiff as usual.Per clinical opinion, the tip kinked easier than usual when the cannula was warmed.The cannula was inserted into the superior vena cava from the right atrium.Limited venous return was encountered.The cannula was initially repositioned but then replaced with another cannula.It is unclear if the exchange of cannula occurred prior to the initiation of bypass and full arrest of the heart.The planned procedure, a mitral valve repair, continued without problems.There was no patient injury.
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Manufacturer Narrative
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Additional manufacturer narrative: the device history record (dhr) was reviewed for the lot number provided, and showed the device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.A manufacturing defect was not confirmed.The devices were not available for return.The complaint condition could not be confirmed.The instructions for use (ifu) was reviewed, and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.
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Search Alerts/Recalls
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