Catalog Number IAB-05840-LWS |
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 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported by the rn that they were unable to get an arterial pressure waveform and when the doctor attempted to flush the line it was leaking.Therefore, the md decided to remove the intra-aortic balloon catheter (iabc) and not replace it.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of central lumen occluded is confirmed.Upon aspiration and flushing, a large amount of 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.Numerous bends were also noted to the central lumen which can result in a dampened pressure reading.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.
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Event Description
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It was reported by the rn that they were unable to get an arterial pressure waveform and when the doctor attempted to flush the line it was leaking.Therefore, the md decided to remove the intra-aortic balloon catheter (iabc) and not replace it.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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