Model Number PRIMO2X |
Device Problem
Low Readings (2460)
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Patient Problems
Abnormal Blood Gases (1034); Death (1802); Blood Loss (2597)
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Event Date 12/15/2017 |
Event Type
Death
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Manufacturer Narrative
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The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the primo2x oxygenator.The incident occurred in (b)(6), usa.(b)(4).The review of the dhr for the reported perfusion tubing set lot confirmed that the device was released in compliance with manufacturer specifications.The pump record and involved oxygenator were returned to livanova usa to be decontaminated before returning to sorin group (b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet received.
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Event Description
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Sorin group (b)(4) received a report that a low po2 value was recorded for a primo2x oxygenator during a circulatory-arrest case.The user reportedly checked the connections to make sure gas was flowing to the oxygenator.The fio2 was turned up as the patient was cooled to 18°c and the po2 declined.An o2 tank was connected as the patient was warmed, but they were unable to reach the expected po2 value.The oxygenator was changed out and the patient was taken off bypass.The patient experienced some bleeding issues and reportedly expired on (b)(6) 2017.
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the primo2x oxygenator.The incident occurred in (b)(6).(b)(4).The involved oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection of the device found no defect.A thorough investigation, including gas flow performance testing, of the returned device was unable to replicate the reported failure.The gas exchange performance (o2t and co2t) of the involved device was in line with product specifications.A review of the oxygenator dhr for the reported lot confirmed that the device was released in compliance with manufacturer specifications.As no pump-sheet of the case was provided for analysis and the issue could not be reproduced, a root cause could not be determined.
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Search Alerts/Recalls
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