Catalog Number IAB-05840-LWS |
Device Problems
Device Alarm System (1012); 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 11/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).For related event see mdr #3010532612-2018-00376 and tc # (b)(4).
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Event Description
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It was reported by the medical doctor that the intra-aortic balloon (iab) ruptured.The intra-aortic balloon pump (iabp) alarmed for possible helium loss.The patient was taken to the operating room to have the iab surgically removed due to a clot formation.A second iab was inserted in the patient.The md stated that the second iab inserted ruptured.When that iab was removed (standard removal procedure), they (unknown who exactly) injected saline into the membrane and there was a visible leak.The dr.Stated that the patient remains in the icu and in critical condition, being medically managed.There was no report of patient death.
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Event Description
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It was reported by the medical doctor that the intra-aortic balloon (iab) ruptured.The intra-aortic balloon pump (iabp) alarmed for possible helium loss.The patient was taken to the operating room to have the iab surgically removed due to a clot formation.A second iab was inserted in the patient.The md stated that the second iab inserted ruptured.When that iab was removed (standard removal procedure), they (unknown who exactly) injected saline into the membrane and there was a visible leak.The dr.Stated that the patient remains in the icu and in critical condition, being medically managed.There was no report of patient death.
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Manufacturer Narrative
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(b)(4).For related event see mdr #3010532612-2018-00376 and tc #1900064631.Teleflex did not receive the device for investigation therefore the reported complaint of 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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Search Alerts/Recalls
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