Model Number IPN000254 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 07/29/2020 |
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 the nurse saw flecks of blood in the intra-aortic balloon (iab) driveline associated with a helium loss alarm.As a result, the ruptured iab was removed in the unit and the second iab was placed in the opposing femoral artery.There was no report of patient consequence or death.
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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.During the investigation, blood was confirmed within the iabc helium pathway.The iabc was returned with a damaged bladder.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The root cause of how the blood entered the helium pathway 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.
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Event Description
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It was reported that the nurse saw flecks of blood in the intra-aortic balloon (iab) driveline associated with a helium loss alarm.As a result, the ruptured iab was removed in the unit and the second iab was placed in the opposing femoral artery.There was no report of patient consequence or death.
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Search Alerts/Recalls
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