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 10/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see related complaint (b)(4).
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Event Description
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It was reported by the rn that intra-aortic balloon (iab) catheter central lumen may be clotted.They have attempted to draw blood back and flush, but are not able to do either.The rn is calling to see if it is safe to leave the iab in like this.There is a radial a-line that is being used as the ap source for the pump, and the waveform is good.The clinical support specialist (css) and rn discussed capping the central lumen, and marking it as not to be accessed.There was no report of delay in therapy.No reported patient death or complications.
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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 central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: see related complaint (b)(4).
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Event Description
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It was reported by the rn that intra-aortic balloon (iab) catheter central lumen may be clotted.They have attempted to draw blood back and flush, but are not able to do either.The rn is calling to see if it is safe to leave the iab in like this.There is a radial a-line that is being used as the ap source for the pump, and the waveform is good.The clinical support specialist (css) and rn discussed capping the central lumen, and marking it as not to be accessed.There was no report of delay in therapy.No reported patient death or complications.
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Search Alerts/Recalls
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