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	Incorrect Measurement (1383)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.The se found pin 3 on one of the cables loose in the connector.It was noted that this wire was one of the two inferior vena cava (ivc) pressure signal wires.The connector did not have any damage and the se pushed the pin into place in the connector to secure it.The pin was no longer loose after it clicked into place properly.Pressure readings on the graphical user interface (gui) were stable afterwards throughout testing, including when moving and straining the signal cabling.The se tested the system with the pressure checker as well and all tests were normal.The root cause of the pressure sensor issue was attributed to the connector not being assembled properly from manufacturing resulting in a loose pin.
Event or Problem Description
The device user (du) reported that the metra was not transitioning from preparation mode to liver on board mode.Troubleshooting was attempted at first with no resolution.The surgeon was guided through further troubleshooting by a clinical research engineer (cre) to increase arterial pressure and induce liver on board mode.It was determined that the inferior vena cava (ivc) pressure sensor was not functioning properly.The ivc pressured consistently measured as 19 mmhg throughout the perfusion.Subsequently, the du decided to discard the doner liver due to unstable perfusion caused by excessive bleeding and inability to control hemostasis.The reported pressure failure was said to have contributed to early perfusion instability also.

• 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: 20615395
• Report Number: 3011560054-2024-00095
• Device Sequence Number: 12646097
• 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
• Report Date (Section B): 11/05/2024

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: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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