SORIN GROUP ITALIA SRL INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS
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Catalog Number 050712 |
Device Problems
Fluid/Blood Leak (1250); Overfill (2404)
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Patient Problems
Blood Loss (2597); Patient Problem/Medical Problem (2688)
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Event Date 09/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was not provided.The complained inspire 8 start oxygenator (catalog number 050712, lot 1607140198), is a sterile device that is not distributed in the usa.As the product item 050712 is not distributed in the usa, the udi is not applicable.The oxygenator item 050712 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050712 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433).Sorin group (b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion.The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected.However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir.To continue the procedure, the medical team elected to change out the entire system.The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care.According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased.At the present date, the patient has not been discharged from intensive care.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation has been completed.Device not yet returned to manufacturer.
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Event Description
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Sorin group (b)(4) received a report that the reservoir of the inspire 8 oxygenator began gradually filling 30 minutes after starting the ecc case, right after circulation was stopped to initiate the cerebral perfusion.The arterial and venous lines were clamped, the vacuum was interrupted and the gas inlet line was disconnected.However, the reservoir kept filling up and blood began leaking from the upper part of the reservoir.To continue the procedure, the medical team elected to change out the entire system.The change-out took nearly 20 minutes and the patient was transfused 9 units of blood and transferred into intensive care.According to the perfusionists, the level of the water in the tank of the heater-cooler had decreased.At the present date, the patient has not been discharged from intensive care.
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Manufacturer Narrative
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(b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The complained device was returned to sorin group (b)(4) for investigation and the water and blood compartments of the returned oxygenator module were leak tested.The blood compartment was filled and pressurized at 1.5 bar (1.5 times the maximum recommended pressure, per the instructions for use) for 30 minutes while monitoring for any leaks into the water compartment.No leaks were detected during this testing.A similar test was repeated at the water side.Again, no leaks were identified during this testing.In order to exclude blood clots occluding the potential leaking area, the water compartment was tested at 38°c for 2 hours and again at 20°c for another two hours.No leaks across the compartments were observed during this time.The reported issue was not reproduced and the unit behaved as expected.As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified.Sorin group (b)(4) has determined that the reported issue is not ascribable to an issue with the device.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
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