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	High Readings (2459)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.The se repeated oxygen concentrator testing several times and measurements were normal.They also checked the air pump and divertor valve function.Perfusion data was downloaded from the device and uploaded for review.The device data was reviewed by a member of the clinical team and it was determined that no issues were identified.The root cause of the reported issue could not be determined based on the information available.
Event or Problem Description
The device user (du) reported concerns with po2 discrepancy between the metra and their blood gas device one hour into the perfusion.While troubleshooting was being completed, it appeared that the issue might be a fluctuating po2 which gave the appearance of a difference.It was confirmed the flows were stable.The du plotted the po2 on the graphical user interface (gui) to confirm historical po2 levels which showed lots of variation.An image of the gui showed four percent o2 delivery to the liver.A manual calibration was completed which showed a small offset of 12kpa to 7kpa which the du was pleased with.However, subsequently the du reached out again to report that the instability of po2 returned.The liver was discarded because viability criteria was not met.In particular, lactate increased drastically after an initial drop before the oxygenation issue.In addition, biliary parameters worsened towards the end of perfusion.

• 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
• Manufacturer (Section G): INTEGRATED TECHNOLOGIES LTD; viking house; ellingham way; ashford, kent, gb TN23 6NF; UK TN23 6NF
• Manufacturer Contact: ruth colwill ; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2-WB ; UK OX4 2WB
• MDR Report Key: 20311276
• Report Number: 3011560054-2024-00086
• Device Sequence Number: 8883287
• Product Code: QQK
• UDI-Device Identifier: 05060462240005
• UDI-Public: 5060462240005
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P200035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown