Catalog Number IAB-S840C |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Venipuncture (2129); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/31/2017 |
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 in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding.The doctor replaced a new one to conduct the treatment".There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient.The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery.There was no reported patient death, injury or complications.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for analysis.The reported complaint that there was a leak at the hub of the central lumen is confirmed.Although, the root cause is undetermined during functional testing, a crack was found at the injection site of the bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.A device history record (dhr) review was conducted for the lot number/serial 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.This issue will be monitored for developing trends.
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Event Description
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It was reported that in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding.The doctor replaced a new one to conduct the treatment".There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient.The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery.There was no reported patient death, injury or complications.
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Search Alerts/Recalls
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