Model Number IPN000254 |
Device Problems
Infusion or Flow Problem (2964); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/07/2020 |
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 (iab) was inserted into the patient without difficulties.When pumping initiated the staff immediately received an alarm for high pressure.The perfusionist also stated that the guidewire appeared "kinked" when it was removed.As a result, the iab was removed and a new iab was used with the same insertion site.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 report complaint of iab high pressure alarm is confirmed.During the investigation, numerous bends and damage was noted to the central lumen and some areas of the outer lumen.A high-pressure alarm could be triggered due to a kink or bend during therapy.The root cause of the complaint is undetermined.A potential cause is customer handling.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 the intra-aortic balloon (iab) was inserted into the patient without difficulties.When pumping initiated the staff immediately received an alarm for high pressure.The perfusionist also stated that the guidewire appeared "kinked" when it was removed.As a result, the iab was removed and a new iab was used with the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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