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	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a liver was placed on the device at 2 am utc for logistics.It was noted that arterial flow had steadily dropped since the start of the case, peaking at 0.3 l/min.The device user (du) team had adjusted the cannula position with some improvement (0 to 0.1 l/min), but subsequently the flow had fallen again.The du had ensured the syringe driver was functioning and it was confirmed that approximately 5 ml of infusions were delivered in correlation to the 5 hours of perfusion at the time.Volume was safely removed from the reservoir to confirm that the reservoir was not too full.Flows improved briefly afterwards, but returned back to 0 l/min.Then, the du returned to the liver bowl to check the artery and while looking at arterial pressure could not see any improvement.They also confirmed that the airknot was not placed too tightly or highly on the arterial cannula.Subsequently, it was decided the liver would be discarded.
Additional Manufacturer Narrative
The product support manager (psm) evaluated the device at the organox maintenance center.Both inferior vena cava (ivc) and portal flows showed 0.0 during the time when there was no flow.No flow offset was identified.Arterial, portal, and ivc flow values were measured using an external independent flow measurement device with no significant difference identified between the flow meter and the gui screen.Review of the reported event data concluded the ascites level sensor continued to activate during the case indicating the liver was bleeding continuously.This can lead to low ivc flow readings and as a result this situation can result in lower than actual arterial flow measurements.However, the root cause of the reported issue could not be definitively determined.

• 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: 20684512
• Report Number: 3011560054-2024-00102
• Device Sequence Number: 12622604
• 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): 11/14/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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