Model Number D0003 |
Device Problem
Power Problem (3010)
|
Patient Problem
Liver Damage/Dysfunction (1954)
|
Event Date 02/15/2024 |
Event Type
Injury
|
Event Description
|
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
|
|
Manufacturer Narrative
|
The device was returned to organox for complaint investigation.Root cause investigation is in progress.
|
|
Manufacturer Narrative
|
A service engineer (se) evaluated the device and determined that the power supply unit needed to be replaced.After the part was replaced, the device passed testing.
|
|
Event Description
|
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
|
|
Event Description
|
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
|
|
Manufacturer Narrative
|
A service engineer (se) evaluated the device and determined that the power supply unit needed to be replaced.After the part was replaced, the device passed testing.Please note that importer report 3022300078-2024-00002, follow up 1, was mistakenly submitted by the device manufacturer.This importer report 3022300078-2024-00002, follow up 2, is identical to the report mistakenly submitted by the manufacturer.
|
|
Manufacturer Narrative
|
Data from the perfusion case was downloaded and reviewed.The data review did not indicate any malfunction of the charging system or within the application of the device.An inspection of the power supply identified burned elements on the primary supply input stage.The power supply will be returned to the supplier and a scar will be requested.
|
|
Event Description
|
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
|
|
Search Alerts/Recalls
|