MAUDE Adverse Event Report: ORGAN RECOVERY SYSTEMS, INC. LIFEPORT KIDNEY TRANSPORTER SYSTEM; PERFUSION CIRCUIT

Model Number LKT200

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information does not apply.The device has no patient contact.Outcomes attributed to adverse event do not apply.Relevant tests / laboratory data do not apply.Other relevant history does not apply.Suspect product(s) do not apply.Serial number does not apply.Devices is not implanted; therefore, implant/explant dates do not apply.Reprocessor does not apply.User facility / importer does not apply.Ind does not apply.Adverse event term(s) do not apply.Initial report: follow-up type does not apply.Explanations for the event problem and evaluation codes are described below.(b)(4).Method code: the investigator visually inspected the returned perfusion circuit and found that the luer connection between the sample port and the filter tube was disconnected.Residue from perfusion solution could be seen within the threads of the luer lock, providing evidence of the leakage.The components of the luer fitting did not show any cracks, deformation or damage, and were tightened by the investigator in accordance with the instructions for use.The device was then loaded onto a lkt101p lifeport kidney transporter and functionally tested, using water to simulate perfusate and blue food dye to aid in identifying the leak.A leak was identified at the luer fitting and the customer's complaint was confirmed.Complaint data and batch records were also reviewed.Correction/removal reporting number does not apply.

Event Description

Organ recovery systems (ors) received a customer complaint that the lkt200 leaked fluid.The transplant center decided to discard the kidney.

• Brand Name: LIFEPORT KIDNEY TRANSPORTER SYSTEM
• Type of Device: PERFUSION CIRCUIT
• Manufacturer (Section D): ORGAN RECOVERY SYSTEMS, INC.; 1 pierce place; suite 475w; itasca, il
• Manufacturer (Section G): ORGAN RECOVERY SYSTEMS, INC.; 1 pierce place; suite 475w; itasca, il
• Manufacturer Contact: roxanne geary ; 1 pierce place; suite 475w; itasca, il ; 8242600
• MDR Report Key: 10270732
• MDR Text Key: 202267743
• Report Number: 3004068499-2020-00009
• Device Sequence Number: 1
• Product Code: KDN
• UDI-Device Identifier: 00815045020032
• UDI-Public: (01)00815045020032(10)122194(17)211230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2020

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: Health Professional
• Device Expiration Date: 12/30/2021
• Device Model Number: LKT200
• Device Catalogue Number: LKT200
• Device Lot Number: 122194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2019
• 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): Required Intervention