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Model Number IPN000260 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/23/2020 |
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 pump (iabp) alarmed for gas helium leak, and blood was noted in the intra-aortic balloon (iab).As a result, the doctor removed the iab.A second iab was not inserted, as the condition of the patient was getting better and the patient was set to be off the iabp.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.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.Additional information received from the reporter for the correct material that was used.A 40cc iab was not used in the event.A 30 cc iab was used during the event.Other remarks:.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) alarmed for gas helium leak, and blood was noted in the intra-aortic balloon (iab).As a result, the doctor removed the iab.A second iab was not inserted, as the condition of the patient was getting better and the patient was set to be off the iabp.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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