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

Catalog Number	D0146
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The device user (du) reported that there was little to no flow noted after the liver was connected to the device.During troubleshooting a darkened area at the top of the soft shell reservoir was noted and air was observed in the tubing.The decision was made to remove the liver and cold flush to avoid warm ischaemia time.Following additional troubleshooting, the du discovered a clot in the portal cannula.The device was cleared of air and preparation mode was achieved.It was confirmed that the du used the recommended infusions, bolus drugs & priming steps.About one hour later the du reported that the device entered low reservoir mode.This was resolved by manipulating the recirculation pump sensor resulting in the volume in the bowl recirculating into the reservoir.Ultimately, the du decided to discard the donor liver due to failure to clear lactate and failure to maintain ph even though the flows were fine once the clot was removed.
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.No physical defects were identified.The pinch valves had no signs of blood ingress and moved freely.The se tested the device flow at prep mode.No issues were observed.Stable flows were confirmed during liver on board mode with a service set.No issues identified during the device evaluation.Review of device event data concluded flows were as expected during the reported event when the device was in preparation mode, but the arterial pressure was low.Low arterial pressure could have been caused by a kink in the arterial line, but this could not be confirmed.No notable flow was achieved for the 24 minutes of the initial perfusion per the results of the data review.The root cause of the reported event is undetermined currently.The disposable set used during the reported event was returned to the manufacture and then sent to the supplier.A supplier corrective action request (scar) has been initiated.The scar findings are pending.
Additional Manufacturer Narrative
The disposable set was returned on july 2, 2024.The root cause investigation is pending.A follow report will be submitted once additional information is available.
Event or Problem Description
The device user (du) reported that there was little to no flow noted after the liver was connected to the device.During troubleshooting a darkened area at the top of the soft-shell reservoir was noted and air was observed in the tubing.The decision was made to remove the liver and cold flush to avoid warm ischaemia time.Following additional troubleshooting, the du discovered a clot in the portal cannula.The device was cleared of air and preparation mode was achieved.It was confirmed that the du used the recommended infusions, bolus drugs & priming steps.About one hour later the du reported that the device entered low reservoir mode.This was resolved by manipulating the recirculation pump sensor resulting in the volume in the bowl recirculating into the reservoir.Ultimately, the du decided to discard the donor liver due to failure to clear lactate and failure to maintain ph even though the flows were fine once the clot was removed.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): ORGANOX LIMITED; oxford science park, magdalen; centre, robert robinson avenue; oxford, oxfordshire, gb OX4 4 GA; UK OX4 4GA
• MDR Report Key: 19780106
• Report Number: 3022300078-2024-00014
• Device Sequence Number: 8068340
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/14/2024
• Report Date (Section F): 07/18/2024

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 Expiration Date: 08/12/2024
• Device Catalogue Number: D0146
• Device Lot Number: 11146868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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: 07/18/2024