Model Number 0684-00-0294-01 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 02/14/2020 |
Event Type
Death
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that the patient was taken to cardiac theatre for emergency surgery.Patient arrested in operating theatre prior to the commencement of surgery.During a prolonged resuscitation process the physicians attempted the insertion of three intra-aortic balloon(iab) catheters.Resuscitation was unsuccessful and the patient subsequently died.The cause of death was stated as pulmonary artery tear.The notes also said there was an aortic rupture complicated from iab insertion and iab catheter rupture.The customer said they did not believe the iab insertion had contributed to the patients unfortunate death.This report is for the 1st iab used.A separate report will be submitted for the 2nd and 3rd iab.
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Event Description
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It was reported that the patient was taken to cardiac theatre for emergency surgery.Patient arrested in operating theatre prior to the commencement of surgery.During a prolonged resuscitation process the physicians attempted the insertion of three intra-aortic balloon(iab) catheters.Resuscitation was unsuccessful and the patient subsequently died.The cause of death was stated as pulmonary artery tear.The notes also said there was an aortic rupture complicated from iab insertion and iab catheter rupture.The customer said they did not believe the iab insertion had contributed to the patients unfortunate death.This report is for the 1st iab used.A separate report will be submitted for the 2nd and 3rd iab.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint#: (b)(4).H3 other text: device not returned.
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Search Alerts/Recalls
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