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Model Number N/A |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Death (1802); Respiratory Distress (2045)
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Event Date 11/23/2017 |
Event Type
Death
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death when a getinge iabp/ iab was involved.There was no alleged malfunction of the iabp, and no further information has been provided.If additional information is provided, a supplemental report will be submitted.
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Event Description
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It was initially reported that while supporting patient on a cs300 intra-aortic balloon pump (iabp) with a sensation plus 40cc balloon, a leak occurred in the balloon, and blood flecks were seen in the tubing.The iabp was put on standby and the physician removed the balloon.Therapy was then continued with a replacement balloon and the patient was eventually placed on continuous renal replacement therapy.Subsequently, updated information was received from the customer that the patient expired, and that the patient's death is not attributed to the iabp or the iab.It was also reported that the patient had inferior st-elevation myocardial infarction (stemi) occlusion of the posterior left ventricular branch of coronary artery; chronic total occlusion of the left anterior descending artery being fed from collaterals from the right coronary artery; cardiogenic shock and respiratory distress.Please note that a separate report will be submitted for the intra-aortic balloon complaint.
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Manufacturer Narrative
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Production device history record (dhr) review is not required as there was no alleged failure or malfunction of the intra-aortic balloon pump.(b)(4).
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Event Description
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It was initially reported that while supporting patient on a cs300 intra-aortic balloon pump (iabp) with a sensation plus 40 cc balloon, a leak occurred in the balloon, and blood flecks were seen in the tubing.The iabp was put on standby and the physician removed the balloon.Therapy was then continued with a replacement balloon and the patient was eventually placed on continuous renal replacement therapy.Subsequently, updated information was received from the customer that the patient expired, and that the patient's death is not attributed to the iabp or the iab.It was also reported that the patient had inferior st-elevation myocardial infarction (stemi) occlusion of the posterior left ventricular branch of coronary artery; chronic total occlusion of the left anterior descending artery being fed from collaterals from the right coronary artery; cardiogenic shock and respiratory distress.Please refer to related intra-aortic balloon report #2248146-2017-00721.
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Search Alerts/Recalls
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