Catalog Number IAB-05840-U |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).For related complaint see mdr #3010532612-2018-00182 and tc (b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted and the doctor was unable to get the blood to return through the central lumen.As a result, another iab was used.Patient condition was reported as fine.There was no reported patient injury or clinical consequence.
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Manufacturer Narrative
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(b)(4).For related complaint see mdr #3010532612-2018-00182 and tc #(b)(4).Teleflex received the device for investigation.The reported complaint of central lumen occluded is confirmed.Upon aspiration and flushing, blood exited the central lumen but the test was successfully completed.The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.Other remarks:.
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted and the doctor was unable to get the blood to return through the central lumen.As a result, another iab was used.Patient condition was reported as fine.There was no reported patient injury or clinical consequence.
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Search Alerts/Recalls
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