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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oxygenator has been obtained from the customer.A supplier corrective action request (scar) has been initiated to further investigate the issue.Evaluation of the part by the supplier is pending.
Event or Problem Description
Device user (du) noticed perfusate leaking at the oxygenator connection.Priming was paused while the connection was assessed.Du was able to manually tighten the connection with initial resolution.Priming was then resumed but the leak continued.The disposable set was changed.No further issue occurred after a new disposable set was used.
Additional Manufacturer Narrative
The supplier received the oxygenator and pictures of the leak that was reported.The supplier completed a formal investigation.No abnormalities were identified from review of the pictures.No issues were identified from the production records review.Complaint database analysis revealed no further similar issue for the associated lot.Visual inspection of the involved oxygenator did not reveal any visible damage that could have caused the reported leak.A leak test was performed.No leak was reproduced.The cardioplegia connector was inspected and a groove was found inside the connector.The connector was then tested on another oxygenator and confirmed to not leak.Further leak test was performed exceeding the maximum internal pressure value permitted.No leak occurred.The most likely root cause of the reported issue is a misaligned tightening of the connector, resulting in the groove inside the cardioplegia connector and the reported leak.But this could not be confirmed definitively.The supplier maintains and documents periodic complaints monitoring to evaluate need for improvements.No specific corrective or preventive action were deemed necessary as a result of the investigation.
Event or Problem Description
Device user (du) noticed perfusate leaking at the oxygenator connection.Priming was paused while the connection was assessed.Du was able to manually tighten the connection with initial resolution.Priming was then resumed but the leak continued.The disposable set was changed.No further issue occurred after a new disposable set was used.
Event or Problem Description
Device user (du) noticed perfusate leaking at the oxygenator connection.Priming was paused while the connection was assessed.Du was able to manually tighten the connection with initial resolution.Priming was then resumed but the leak continued.The disposable set was changed.No further issue occurred after a new disposable set was used.
Additional Manufacturer Narrative
Subsequently, it has been decided to update the device instruction for use (ifu), as a precaution, to include a recommendation for the device user to ensure the system pressure and flow rates are within limits and there are no leaks during priming prior to adding blood.

• 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
• Manufacturer (Section G): RAUMEDIC - MUENCHBERG; hermann-staudinger strasse 2; helmbrechts, bavaria, de 95233 ; GM 95233
• Manufacturer Contact: ruth colwill ; oxford science park, magdalen; centre, robert robinson avenue; oxford, oxfordshire, gb OX4 4-GA ; UK OX4 4GA
• MDR Report Key: 19192139
• Report Number: 3011560054-2024-00039
• Device Sequence Number: 15543986
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• 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,Followup,Followup
• Report Date (Section B): 09/14/2024

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 Expiration Date: 11/29/2024
• Device Catalogue Number: D0146
• Device Lot Number: 11152457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 04/01/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/17/2024; 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown