MAUDE Adverse Event Report: ORGAN RECOVERY SYSTEMS. INC. LIFEPORT KIDNEY TRANSPORTER SYSTEM

Model Number LKT100P, LKT200

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information does not apply.The device has no contact with patient.System consists of two devices: lkt100p unit and lkt200 cassette.Serial number is associated with lkt100p and lot number is associated with lkt200.

Event Description

On (b)(6) 2019, organ recovery system (ors) received a customer ((b)(6)) complaint that the lkt100p failed to signal an alarm due to low fluid level and that lkt200 leaked fluid.This complaint is cross-referenced with fda medwatch report number mw5086095.

• Brand Name: LIFEPORT KIDNEY TRANSPORTER SYSTEM
• Type of Device: KIDNEY TRANSPORTER SYSTEM
• Manufacturer (Section D): ORGAN RECOVERY SYSTEMS. INC.; 1 pierce place; suite 475w; itasca IL 60143
• Manufacturer (Section G): ORGAN RECOVERY SYSTEMS, INC.; 1 pierce place; suite 475 w; itasca IL 60143
• Manufacturer Contact: roxanne geary ; 1 pierce place; suite 475w; itasca, IL 60143 ; 8478242436
• MDR Report Key: 9041344
• MDR Text Key: 164257241
• Report Number: 3004068499-2019-00001
• Device Sequence Number: 1
• Product Code: KDN
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: LKT100P, LKT200
• Device Catalogue Number: LKT100P, LKT200
• Device Lot Number: 73588264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1