MAUDE Adverse Event Report: ORGANOX LIMITED ORGANOX METRA; NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR

Catalog Number	D0003
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event data from the device was retrieved and reviewed.Evidence of downward trending flows was confirmed.However, root cause of the issue could not be determined from the data review.A service engineer evaluated the device at the customer site.The device was tested in both preparation and liver on board mode.The device consistently maintained and regulated pressures and flow rates as expected.The device passed all testing completed.
Event or Problem Description
The device user (du) reported arterial flow was low.Initially arterial flow was good (0.4l/min).But, it tapered off after a few minutes.As a result of the flow issue, the du decided to discard the donor liver.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): ORGANOX LIMITED; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2 WB; UK OX4 2WB
• MDR Report Key: 20212855
• Report Number: 3022300078-2024-00017
• Device Sequence Number: 12563445
• Product Code: QQK
• UDI-Device Identifier: 05060462240005
• UDI-Public: 5060462240005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2024
• Report Date (Section F): 09/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/16/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/13/2024