Model Number IPN000263 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
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Event Date 04/01/2020 |
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 blood was found in the helium pipeline during blood aspiration after the intra-aortic balloon (iab) was inserted on the right femoral artery.When the staff removed the iab there was blood noted in the balloon.As a result, a new iab was used to complete treatment and a new insertion site was used at the left femoral artery.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 reported complaint of iab blood in helium pathway is confirmed.Multiple leak sites were noted on the iab bladder, with the appearance of the leak sites consistent with contact from a sharp object.The root cause of how the catheter came into contact with a sharp object is undetermined, but a potential cause is due to 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.No further action is required.
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Event Description
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It was reported that blood was found in the helium pipeline during blood aspiration after the intra-aortic balloon (iab) was inserted on the right femoral artery.When the staff removed the iab there was blood noted in the balloon.As a result, a new iab was used to complete treatment and a new insertion site was used at the left femoral artery.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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