Catalog Number IAB-05830-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 03/04/2018 |
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 that the central lumen clotted during use on a patient.During therapy, blood was noted to be "creeping back" the central lumen tubing.There was an attempt to flush the central lumen, but could not.The intra-aortic balloon (iab) was not removed due to central lumen clotting off.The fiber optic sensor (fos) was working fine for signal and timing.As a result, the physician was notified and the central lumen was labeled to "not attempt to flush".There was no report of delay of interruption of therapy.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 did not receive the device for investigation therefore the reported complaint of "iab central lumen occluded" is not able to be confirmed.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.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.No further action required at this time.
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Event Description
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It was reported that the central lumen clotted during use on a patient.During therapy, blood was noted to be "creeping back" the central lumen tubing.There was an attempt to flush the central lumen, but could not.The intra-aortic balloon (iab) was not removed due to central lumen clotting off.The fiber optic sensor (fos) was working fine for signal and timing.As a result, the physician was notified and the central lumen was labeled to "not attempt to flush".There was no report of delay of interruption of therapy.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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