MAUDE Adverse Event Report: Organ Recovery Systems LifePort Kidney Transporter (LKT101P); System, Perfusion, Kidney

Model Number	LKT101P
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction

• Brand Name: LifePort Kidney Transporter (LKT101P)
• Common Device Name: System, Perfusion, Kidney
• Manufacturer (Section D): Organ Recovery Systems; one pierce place; suite 475w; itasca IL 60143
• Manufacturer Contact: chris hill ; one pierce place; suite 475w; itasca, IL 60143
• MDR Report Key: 50159197
• Report Number: 3004068499-2026-00002
• Device Sequence Number: 10603133
• Product Code: KDN
• UDI-Device Identifier: 00815045020018
• UDI-Public: 00815045020018
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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 Model Number: LKT101P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown