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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.The se replaced the loose colder products company (cpc) connector on the water circuit with a new connector and gasket.The device tested successfully with no leaks afterwards.A corrective and preventative action (capa) was initiated to further investigate this issue.The root cause of the issue is suspected to be related to the manufacturing procedure not providing clear torquing instructions, such as the proper torquing forces and proper tools for connections.Detailed torquing specifications will be added to the manufacturing drawings and procedures used in assembling the connectors.Additionally, the proper tooling needed to meet torquing specifications will be clarified within the manufacturing drawings and procedures.
Event or Problem Description
The device user (du) reported that there was a loose water connection on the device.They were asked to ensure it was properly heating perfusate and they confirmed that it was working fine at the time.

• 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: 20284978
• Report Number: 3011560054-2024-00084
• Device Sequence Number: 8013462
• 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): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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
• Patient Sex: Unknown