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 Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation for this complaint is currently underway, but has not yet been completed.A follow-up report will be filed to reflect the results of the investigation.Internal document numbers are (b)(4).

Event Description

On (b)(6) 2020, organ recovery systems (ors) received a customer complaint that the lkt200 leaked fluid.The transplant center decided to discard the kidney.

Manufacturer Narrative

Capa-000056 has been initiated to address this failure mode associated with the rework of lot 119944.D4: unique identifier (udi) # has been corrected.Previous report indicated the di, but not the pi.G1: type of report is indicated.H2: follow-up type is indicated.H3: device evaluated by manufacturer has been updated.H6: method code(s), result code(s), and conclusion code(s) have been updated.

• 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 60143
• MDR Report Key: 9678327
• MDR Text Key: 221303162
• Report Number: 3004068499-2020-00002
• Device Sequence Number: 1
• Product Code: KDN
• UDI-Device Identifier: 00815045020032
• UDI-Public: 00815045020032
• Combination Product (y/n): N
• PMA/PMN Number: K021362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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: 03/18/2021
• Device Model Number: LKT200
• Device Catalogue Number: LKT200
• Device Lot Number: 119944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3004068499-1/30/20-001-R
• Patient Sequence Number: 1