Model Number D0146 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Liver Damage/Dysfunction (1954)
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Event Date 12/18/2023 |
Event Type
Injury
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Event Description
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A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
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Manufacturer Narrative
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Report number (b)(4) submitted to fda by initial reporter.Additionally, it has been confirmed that the event date is actually 18dec2023, not 17dec2023.
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Manufacturer Narrative
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A service engineer (se) evaluated the device.It was determined that the leak resulted from damage to the ascites port spigot on the liver bowl which is believed to have been caused by impact damage prior to the device being delivered to the customer.A supplier corrective action request (scar) has been requested to investigate further.
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Event Description
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A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
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Manufacturer Narrative
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A visual inspection of the liver bowl was performed by the manufacturer at the customer site.It was confirmed that the port had a visible stress crack.The shape and location of the stress crack indicates the port had been subjected to impact damage from the base of the port, but this could not be confirmed definitively.A review of production records by the supplier identified no deviations.The supplier was unable to identify a definitive root cause of the issue.As a precaution, the supplier has implemented an additional action to address this issue by adding rejection criterion for a crack in the ascites spigot port of the liver bowl while conducting the 100% visual inspection.
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Event Description
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A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
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Search Alerts/Recalls
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