Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded and completed the surgery.There was no report of patient complications serious injury or death.
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Event Description
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It was reported that when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded and completed the surgery.There was no report of patient complications serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).No part has been returned to teleflex chelmsford for investigation.The reported complaint of "blood leakage through the anti-reflux valve on the introducer sheath" 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.
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Search Alerts/Recalls
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