Model Number EZC24TA |
Device Problem
Nonstandard Device (1420)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/13/2022 |
Event Type
Injury
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Event Description
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It was reported that the vented connector of an ez glide aortic cannula came loose.There were no patient injuries.Per rep this was a cabg procedure and the event occurred towards the end of the procedure.No exchange of cannula was required.No abnormality of the device or packaging was noted prior to use.
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Manufacturer Narrative
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Additional narratives: these cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.The device was not returned for evaluation, as it was discarded.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that the vented connector of a ezc24ta ez glide aortic cannula separated from the cannula.There were no patient injuries.Per rep this was a cabg procedure and the event occurred towards the end of the procedure.No exchange of cannula was required.No abnormality of the device or packaging was noted prior to use.Per the perfusionist the it came loose at the red-cap.It has to deal with the bonded vent connector site.The perfusionist feels the issue lies within the small vent connector barb and recommends a three barb connector.
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Manufacturer Narrative
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Updated b5 per new information received.
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Manufacturer Narrative
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H10: additional narratives: updated d4, h4, and h6 per new information received.Based on the information available, the complaint of disconnection is confirmed, however, the most likely cause is due to excessive force applied by the user.An edwards defect has not been confirmed.The device history record (dhr) was reviewed and 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.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Search Alerts/Recalls
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