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

Model Number	D0146
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
Additional Manufacturer Narrative
It has been confirmed that the event date is actually (b)(6) 2023, not (b)(6) 2023.
Event or Problem Description
A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
Additional Manufacturer Narrative
A service engineer (se) evaluated the device.It was determined that the leak resulted from damage to the ascites port spigot on the liver bowl which is believed to have been caused by impact damage prior to the device being delivered to the customer.A supplier corrective action request (scar) has been requested to investigate further.
Additional Manufacturer Narrative
A visual inspection of the liver bowl was performed by the manufacturer at the customer site.It was confirmed that the port had a visible stress crack.The shape and location of the stress crack indicates the port had been subjected to impact damage from the base of the port, but this could not be confirmed definitively.A review of production records by the supplier identified no deviations.The supplier was unable to identify a definitive root cause of the issue.As a precaution, the supplier has implemented an additional action to address this issue by adding rejection criterion for a crack in the ascites spigot port of the liver bowl while conducting the 100% visual inspection.
Event or Problem Description
A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.

• 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; hermann-staudinger strasse 2; helmbrechts, bavaria 48149 ; GM 48149
• Manufacturer Contact: ruth colwill ; oxford science park, magdalen; centre, robert robinson avenue; oxford, oxfordshire, gb OX4 4-GA ; UK OX4 4GA
• MDR Report Key: 18896427
• Report Number: 3011560054-2024-00002
• Device Sequence Number: 12364891
• 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): 05/10/2024

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: 08/30/2024
• Device Model Number: D0146
• Device Catalogue Number: D0146
• Device Lot Number: 11148086
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 12/18/2023
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/11/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown