Model Number BE-HLS 7050#HLS SET ADVANCED 7.0 |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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They reported: thrombosis, embolism or tissue embolism to the oxygenator, completely obstructed, no flow on ecmo.The device was exchanged during treatment.No harm to the patient.(b)(4).
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Manufacturer Narrative
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The getinge laboratory received the sample on 2019-07-17.The investigation has been performed by the laboratory on 2019-08-21.During visual inspection massive clots were detected.The failure could be confirmed.The most probable root cause could not be determined.Risk assessment was performed.The risk is covered.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Event Description
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Internal ref#: (b)(4), one support: (b)(4).
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Search Alerts/Recalls
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