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	02/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted as a part of a retrospective review and remediation effort based on enhancements made to the company's complaint handling processes.This event is being filed in accordance with a capa which has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.The device user utilized a blunt needle to softly break the plastic film that was occluding the first location.The device user was able to manipulate the infusion tubing to break the tubing apart in the location of the second occlusion also.These interventions allowed the heparin infusion to be primed, but message code 270 remained.A clinical specialist advised the device user to complete a rapid stop/start of perfusion.The device user completed this action and message code 270 did not display afterwards.The device user was asked to return the infusion tubing so that it can be evaluated.
Event or Problem Description
The device user reported that message code 270 (occluded tubing) displayed on the device screen.The device user was able to determine that a syringe infusion line for heparin was being occluded by a plastic film in two locations.The first location was where the tip of the syringe is screwed into the luer lock.There was plastic film that was occluding the syringe line from being primed.The second location was further up the infusion line where the infusion tubing was stuck together.It was decided to discard the donor liver due to lack of viability.The device user believes that the occulded tubing contributed to the liver not being viable for transplantation.

• 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: 19315704
• Report Number: 3022300078-2024-00006
• Device Sequence Number: 3088466
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 04/01/2024

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 Expiration Date: 10/18/2024
• Device Catalogue Number: D0146
• Device Lot Number: 11149211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/04/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• 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: 04/01/2024