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Model Number IPN000260 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2020 |
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 there was blood found in the helium chamber of the intra-aortic balloon (iab) after working for 10 minutes.As a result, the intra-aortic balloon pump (iabp) was shut down immediately and the iab was removed.The user used a new iab to complete the treatment.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, dried blood was confirmed within the iabc helium pathway.During the investigation, the leak testing of the iabc was unable to be performed successfully.The iabc outer lumen was noted blocked by dried blood and was not able to be cleared.The bladder/helium pathway could not be inflated, and any potential leak site(s) could not be determined.The root cause how the blood entered in 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 revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that there was blood found in the helium chamber of the intra-aortic balloon (iab) after working for 10 minutes.As a result, the intra-aortic balloon pump (iabp) was shut down immediately and the iab was removed.The user used a new iab to complete the treatment.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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