Catalog Number IAB-06840-U |
Device Problems
Complete Blockage (1094); Difficult to Flush (1251)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2019-00342 and (b)(4) as the report is related to the same patient.
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Event Description
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It was reported that after the first intra-aortic balloon (iab) a second iab was inserted.After the second iab was inserted, the staff was again unable to flush the central lumen.The clinical support specialist (css) advised the staff to establish an arterial line from a new radial line or at least the side port from the sheath.As a result, the staff used the side port arterial line.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "unable to flush the central lumen" is confirmed.Upon return, the central lumen failed aspiration and flush testing due to a blood clot.The blood clot was cleared from the central lumen after the guidewire test and another attempt of aspirating and flushing 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2019-00342 and (b)(4) as the report is related to the same patient.
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Event Description
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It was reported that after the first intra-aortic balloon (iab) a second iab was inserted.After the second iab was inserted, the staff was again unable to flush the central lumen.The clinical support specialist (css) advised the staff to establish an arterial line from a new radial line or at least the side port from the sheath.As a result, the staff used the side port arterial line.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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