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Model Number CB1Q91R6 |
Device Problem
Crack (1135)
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Patient Problems
Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597)
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Event Date 09/16/2020 |
Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use, the customer reported the bpx-80 adult bio-pump¿ plus centrifugal pump leaked, and the patient had a large blood loss.The patient was on ecmo on (b)(6) 2020 at 4 pm.At 10pm the patient had bp dropped and cpr was performed.The nurse then found the bio-pump was leaking, so they called the perfusionist.The perfusionist tried to change bio-pump.The patient lost a lot of blood and expired at 10.30 pm.The customer thought the bio-pump may be one of the causes of patient death.Additional information received on october 15th 2020, stated the leak was at the connector between the blood outlet and tubing, and that when the perfusionist was removing the pump head from the external drive, she found the tubing disconnected from the blood outlet easily.Patient medical history: allergy, lung problems.
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Manufacturer Narrative
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Medtronic investigation: a visible leak was noted from the outlet of the pump.Additional information received from the user stated the location of the leak was at the connection between the outlet and tubing, and the user found the tubing disconnected from the outlet easily.Because the device was not returned, the root cause of this complaint could not be determined.Review of the dhr found no abnormalities during the manufacturing process.A clinical review of this event concluded there are no new risks associated with the use of this device.Trends for issues with this product are reviewed at quarterly quality meetings.This investigation was completed with the information that was provided.If additional information is received this investigation will be reopened if deemed necessary.No further actions to be taken at this time.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use, the customer reported the bpx-80 adult bio-pump® plus centrifugal pump leaked, and the patient had a large blood loss.The patient was on ecmo on (b)(6) 2020 at 4 pm.At 10pm the patient had bp dropped and cpr was performed.The nurse then found the bio-pump was leaking, so they called the perfusionist.The perfusionist tried to change bio-pump.The patient lost a lot of blood and expired at 10.30 pm.The customer thought the bio-pump may be one of the causes of patient death.Additional information received on (b)(6) 2020, stated the leak was at the connector between the blood outlet and tubing, and that when the perfusionist was removing the pump head from the external drive, she found the tubing disconnected from the blood outlet easily.Patient medical history: allergy, lung problems.
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Search Alerts/Recalls
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