Catalog Number IAB-R950-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 04/26/2016 |
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 intra aortic balloon was inserted sheathless via the patient's femoral artery on (b)(6) 2016.After insertion the patient was moved from the cath lab to the intensive care unit.On (b)(6) 2016; the arterial pressure flat lined, and the central lumen was found clotted.A heparin flush bag was hooked to central lumen.A radial arterial line was added.The patient is still on the pump in the unit.There was no reported patient death, injury or complications.Intra aortic balloon pump therapy was not delayed or interrupted.Medical / surgical intervention was not required.The pump did not alarm.
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Manufacturer Narrative
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(b)(4) no product was returned for evaluation.Lot history numbers are 18f15g0003 and 18f15m0024.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.
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Event Description
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It was reported that the intra aortic balloon was inserted sheathless via the patient's femoral artery on (b)(6) 2016.After insertion the patient was moved from the cath lab to the intensive care unit.On (b)(6) 2016; the arterial pressure flat lined, and the central lumen was found clotted.A heparin flush bag was hooked to central lumen.A radial arterial line was added.The patient is still on the pump in the unit.There was no reported patient death, injury or complications.Intra aortic balloon pump therapy was not delayed or interrupted.Medical / surgical intervention was not required.The pump did not alarm.
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Search Alerts/Recalls
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