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

Model Number D0146

Device Problem Fluid/Blood Leak (1250)

Patient Problem Liver Damage/Dysfunction (1954)

Event Date 12/18/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

It has been confirmed that the event date is actually (b)(6) 2023, not (b)(6) 2023.

Event 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.

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.

• 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
• 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
• MDR Text Key: 337579357
• Report Number: 3011560054-2024-00002
• Device Sequence Number: 1
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 11148086
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other