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	Complete Blockage (1094)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tubing will not be evaluated because it could not be returned.Further investigation is pending.
Event or Problem Description
The device user reported that they had a liver going on pump overnight.At 327 am est the device user sent a message stating "liver is being discarded.There was a defect in the recirculating pump line that prevented the pump from refilling the reservoir bag.That combined with a heavy bleeder prevented the liver from getting proper perfusion." the device user further described that the tubing under the liver bowl was sealed shut and since it was under the liver bowl, they could not figure out why the recirculating pump was slow.By the time the area was located, it had been a long time with an empty reservoir.It was noted that the seal took several minutes to break and the tubing was almost completely occluded as well.

• 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
• MDR Report Key: 20679745
• Report Number: 3022300078-2024-00022
• Device Sequence Number: 7217641
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2024
• Report Date (Section F): 11/13/2024

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: 02/14/2025
• Device Catalogue Number: D0146
• Device Lot Number: 11154066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• 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: 11/13/2024