Model Number IPN038075 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/16/2020 |
Event Type
Injury
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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 an intra-aortic balloon (iab) was inserted into the patient, but when inflated the monitor did not signal that something had happened.There was a small diastolic bp augmentation noted.The operator saw blood in the balloon and the intra-aortic balloon pump (iabp) was stopped and the iab was pulled out.It seems that the support wire channel in the balloon was broken.The procedure was repeated in the morning with a new iab successfully.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The iabc central lumen was noted detached/separated from the flex-tip assembly, which can cause blood to enter the helium pathway.It could not be confidently determined that how the central lumen detached/separated from the flex-tip assembly, but a potential cause is forceful handling of the device.The root cause of the complaint is undetermined.The complaint is isolated, there are no other complaints with this finding.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.
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Event Description
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It was reported that an intra-aortic balloon (iab) was inserted into the patient, but when inflated the monitor did not signal that something had happened.There was a small diastolic bp augmentation noted.The operator saw blood in the balloon and the intra-aortic balloon pump (iabp) was stopped and the iab was pulled out.It seems that the support wire channel in the balloon was broken.The procedure was repeated in the morning with a new iab successfully.
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Search Alerts/Recalls
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