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

Model Number D0146

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/05/2024

Event Type  Injury  

Event Description

A surgeon reported that "upon removal of the arterial cannula, there was a thrombosis.The liver was still transplanted, but it did increase the time on ice by approximately 30 minutes".

Manufacturer Narrative

The liver was recovered, cannulated, and connected to the device by a surgeon at the (b)(6).During a follow up phone call after the transplant, a member of the clinical team spoke with a surgeon at the implanting transplant facility.The surgeon believed that the arterial cannula had been inserted too far into the hepatic artery, at approximately the depth of the gastroduodenal artery.On removal of the arterial cannula, a thrombus was seen in the hepatic artery.The implanting surgeon was able to trim the vessel and continue with the transplant and hepatic arterial anastomosis.The initial reporter was unable to provide the device lot number.The arterial cannula is believed to have been discarded by the hospital that transplanted the donor liver, thus it could not be evaluated.The root cause of the reported issue is undetermined.

• Brand Name: ORGANOX METRA
• Type of Device: 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: 19040953
• MDR Text Key: 339374203
• Report Number: 3022300078-2024-00003
• Device Sequence Number: 1
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Model Number: D0146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2024
• Distributor Facility Aware Date: 03/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other