Catalog Number IAB-06840-U |
Device Problems
Device Alarm System (1012); Material Puncture/Hole (1504)
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Patient Problems
Atrial Fibrillation (1729); Death (1802); Low Blood Pressure/ Hypotension (1914)
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Event Date 08/19/2017 |
Event Type
Death
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Manufacturer Narrative
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Medical devices: scitation, inotropes administered, patient cardioverted x3 unresponsive to treatment.Dialysis ceased.Qn#(b)(4).
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Event Description
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It was reported that the event occurred during use in the intensive care unit.The intra-aortic balloon (iab) was inserted in the patient and the balloon rapidly filled with blood.As a result, the intra-aortic balloon pump (iabp) was stopped and the balloon catheter was removed.The iab was not replaced.Iabp alarm: high pressure.Further information received: the patient remained in atrial fibrillation and the patient's blood pressure started to trend down.The patient was medically treated.Additional information received: the patient was not affected by removal of the iab.The patient deceased at a time thereafter.
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Manufacturer Narrative
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Concomitant medical products: scitation.Inotropes administered.Patient cardioverted x3 unresponsive to treatment.Dialysis ceased (b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.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.We will continue to monitor for any developing trends.No further action is required at this time.
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Event Description
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It was reported that the event occurred during use in the intensive care unit.The intra-aortic balloon (iab) was inserted in the patient and the balloon rapidly filled with blood.As a result, the intra-aortic balloon pump (iabp) was stopped and the balloon catheter was removed.The iab was not replaced.Iabp alarm: high pressure.Further information received: the patient remained in atrial fibrillation and the patient's blood pressure started to trend down.The patient was medically treated.Additional information received: the patient was not affected by removal of the iab.The patient deceased at a time thereafter.
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Search Alerts/Recalls
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