Model Number 4103202 |
Device Problems
Suction Problem (2170); Difficult to Open or Close (2921); Pressure Problem (3012)
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Patient Problem
Blood Loss (2597)
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Event Date 10/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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There are no more devices of the same lot remaining in inventory for evaluation.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
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Event Description
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The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device.The report stated the device was part of a "sucker line", a negative pressure line used during an ecmo procedure.The report stated that the one-way valve was stuck open, and to resolve the issue a cap was placed on the negative pressure release and another valve was placed proximal to the open valve.The report stated that blood was lost that required a blood transfusion to the patient and an acute pressure drop was observed as a result of the alleged event.The report was completed and no further patient impact was reported.The device was discarded by the end-user and not returned to the distributor or manufacturer for evaluation.The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.
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Manufacturer Narrative
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The device was not returned to the manufacturer for evaluation.There were no more devices of the same lot remaining in inventory for evaluation.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
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Search Alerts/Recalls
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