Catalog Number IAB-06850-U |
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 11/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that blood was noted in the helium tubing.As a result, the iab was removed.The iab was removed without incident or difficulty at the bedside.The patient remained stable to the physician chose to not reinsert a 2nd iab.No patient harm or injury.The patient status is reported as "fine".
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Event Description
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It was reported that blood was noted in the helium tubing.As a result, the iab was removed.The iab was removed without incident or difficulty at the bedside.The patient remained stable to the physician chose to not reinsert a 2nd iab.No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).The reported complaint for "blood noted in helium drive line" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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