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	Failure to Deliver (2338)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.The root cause of the reported issue was determined to be due to the ascites level sensor cable rubbing against the back rotating part of the ascites pump.This caused the pump to overheat from friction and shut off.The issue was resolved by replacing the cable back to the proper position.Afterwards, the device passed functional testing.
Event or Problem Description
At 240 am est, the device user (du) reported low reservoir mode and cycling reservoir issues three hours and thirteen minutes into perfusion.During troubleshooting, it was confirmed that there was volume collecting at the bottom of the liver bowl, but there were no kinks in the tubing.It was recommended that the surgeon inspect the liver to resolve hemostasis.At 333 am est the du reported there were no flows on the machine, the reservoir volume was empty and volume was collecting at the bottom of the liver bowl.Troubleshooting was performed and it was confirmed that the centrifugal pump was working but the ascites pump was not running despite "1" being listed for ascites on the graphical interface screen.After powering the device off and back on, it was confirmed that the ascites pump was functioning and volume was returning to the reservoir.Prior to this resolution, lack of flow lasted about one hour.As a result, the liver's lactate increased from 0.88 to 8.44.The du declined to use the donor liver due to the inability to clear lactate adequately, but continued with the perfusion in case another site wished to take the donor liver.Subsequently, the ascites pump stopped working again.Additional troubleshooting was performed, resulting in the ascites pump functioning normally again.The donor liver was also declined by other sites, thus it was discarded.

• 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: 20344250
• Report Number: 3011560054-2024-00087
• Device Sequence Number: 18142562
• 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): 10/01/2024

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: 09/04/2024
• Initial Report FDA Received Date: 10/01/2024
• 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