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

Model Number D0146

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 341024329
• Report Number: 19180738
• Device Sequence Number: 1
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: (01)05060462240029
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 04/10/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1