Catalog Number 102954 |
Device Problems
Display or Visual Feedback Problem (1184); Pumping Stopped (1503); Battery Problem (2885)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 10/23/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Approximate age of device: the centrimag primary console is not a single use device.Approximate age of the device from manufacture date is 4 years and 11 months.The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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The patient is being supported with an extracorporeal circulatory support device.It was reported that when the patient was being transported after a ct scan back to the intensive care unit the primary console supporting the right ventricle alarmed with a low battery alarm and then the unit stopped.The health care professionals switched the extracorporeal circuit and motor to the backup console and support was resumed.During the event the patient's blood pressure dropped and there was no flow from the right ventricle; however there was no reported adverse sequelae.It was reported that "the low battery event was a malfunction." the console indicated ''battery below minimum'', but the battery gauge showed a full charge.
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Manufacturer Narrative
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Device evaluation: the reported event was confirmed during the evaluation of the returned device.The primary console was charged for 24 hours upon return.Approximately 10 minutes into the battery discharge test, the console displayed the battery below minimum alarm and stopped operating the pump.The internal battery was examined and was close to its expiration date, suggesting that it no longer provided enough battery power to operate the system.Once a new battery was installed, a battery maintenance was performed and the primary console passed the functional checkout without issue.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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