Model Number IPN000263 |
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 12/12/2019 |
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 by the doctor from the catheter room that during use on a patient, the intra-aortic balloon (iab) catheter the balloon was found broken, which causes blood to back up into the pump.The iab catheter was removed and a new catheter was used.There was no report of patient serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported by the doctor from the catheter room that during use on a patient, the intra-aortic balloon (iab) catheter the balloon was found broken, which causes blood to back up into the pump.The iab catheter was removed and a new catheter was used.There was no report of patient serious injury or death.
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Search Alerts/Recalls
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