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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device data from the event was reviewed and evidence of low po2 was confirmed.It is suspected that the low po2 was caused by the device user not properly connecting the oxygen concentrator line.However, this could not be confirmed based on the limited information available.A service engineer (se) evaluated the device at the customer site.The se performed numerous start/stop tests with a 5 second pause between button presses.There were no observations noted.The se also completed several more start/stops with shorter wait times between button presses (approximately 1 second) with no observations noted.The se removed the back cover and pulled data while verifying that the cabling to the cobra and inogen were secure with nothing unusual observed.The cobra was replaced with updated firmware.The liver was discarded due to lack of glucose metabolism.The device user stated they did not believe that the issue with the oxygenator contributed to the liver discard.
Event or Problem Description
It was reported that the oxygenator was dark and not getting oxygen delivered.The customer was asked to ensure the concentrator line was plugged in correctly.They were able to remove and reconnect the line with no change.Message codes 410 (low blood oxygen levels) and 2410 (critical fault reported) were present on the screen.The customer was then asked to perform a stop start and the issue was resolved.The customer ensured that the levels of po2 were rising and stabilizing.
Event or Problem Description
It was reported that the oxygenator was dark and not getting oxygen delivered.The customer was asked to ensure the concentrator line was plugged in correctly.They were able to remove and reconnect the line with no change.Message codes 410 (low blood oxygen levels) and 2410 (critical fault reported) were present on the screen.The customer was then asked to perform a stop start and the issue was resolved.The customer ensured that the levels of po2 were rising and stabilizing.
Additional Manufacturer Narrative
Device data from the event was reviewed and evidence of low po2 was confirmed.It is suspected that the low po2 was caused by the device user not properly connecting the oxygen concentrator line.However, this could not be confirmed based on the limited information available.A service engineer (se) evaluated the device at the customer site.The se performed numerous start/stop tests with a 5 second pause between button presses.There were no observations noted.The se also completed several more start/stops with shorter wait times between button presses (approximately 1 second) with no observations noted.The se removed the back cover and pulled data while verifying that the cabling to the cobra and inogen were secure with nothing unusual observed.The cobra was replaced with updated firmware.The liver was discarded due to lack of glucose metabolism.The device user stated they did not believe that the issue with the oxygenator contributed to the liver discard.

• 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: 20184762
• Report Number: 3011560054-2024-00080
• Device Sequence Number: 18375571
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2016
• 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
• Patient Sex: Unknown