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

Model Number	D0146
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing the organ ox pump for liver donor organ, it was noted that there was a faulty connection from the one time use cassette.A slow leak at the level of the oxygenator from the cannula originating from the liver bowl not responsive to manual tightening was discovered upon infusion of perfusate.Perfusate was then infused back into bags using sterile technique under gravity and a new cassette was installed and continued prep as normal.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): ORGANOX LIMITED; 7 giralda farms suite 130; madison NJ 07940
• MDR Report Key: 19180738
• Report Number: 19180738
• Device Sequence Number: 6989222
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: (01)05060462240029
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2024
• Report Date (Section F): 04/10/2024

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: Other
• Device Model Number: D0146
• Device Catalogue Number: D0146
• Device Lot Number: 11152457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/10/2024