MAUDE Adverse Event Report: Organ Recovery Systems LifePort Kidney Transporter (LKT101P)

Model Number	LKT101P
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Lifesource - upper midwest organ procurement organization, based in (b)(6), reported that a lifeport kidney transporter (lkt101p) malfunctioned during air transport of a donor kidney.Upon landing, customer observed a pressure alarm and reported that the lkt101p stopped pumping/perfusing the donor kidney.The donor kidney (unos is (b)(6) remained in cold storage after perfusion ceased.The transplant surgeon declined the donor kidney due to evidence of petechiae on the kidney and the lkt101p malfunction.
Additional Manufacturer Narrative
The lkt101p device that malfunctioned will be evaluated by the manufacturer, organ recovery systems, once the product has been returned by the customer.

• Brand Name: LifePort Kidney Transporter (LKT101P)
• Common Device Name: LifePort Kidney Transporter
• 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: 50201323
• Report Number: 3004068499-2026-00001
• Device Sequence Number: 10274436
• Product Code: KDN
• UDI-Device Identifier: 00815045020018
• UDI-Public: 00815045020018
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (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