LIFEPORT KIDNEY TRANSPORTER SYSTEM LKT100P, LKT200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for LIFEPORT KIDNEY TRANSPORTER SYSTEM LKT100P, LKT200 manufactured by Organ Recovery Systems. Inc..

MAUDE Entry Details

• Report Number: 3004068499-2019-00001
• MDR Report Key: 9041344
• Date Received: 2019-09-13
• Date of Report: 2019-09-13
• Date of Event: 2019-04-10
• Date Mfgr Received: 2019-04-11
• Device Manufacturer Date: 2019-01-10
• Date Added to Maude: 2019-09-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. ROXANNE GEARY
• Manufacturer Street: 1 PIERCE PLACE SUITE 475W
• Manufacturer City: ITASCA IL 60143
• Manufacturer Country: US
• Manufacturer Postal: 60143
• Manufacturer Phone: 8478242436
• Manufacturer G1: ORGAN RECOVERY SYSTEMS, INC.
• Manufacturer Street: 1 PIERCE PLACE SUITE 475 W
• Manufacturer City: ITASCA IL 60143
• Manufacturer Country: US
• Manufacturer Postal Code: 60143
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LIFEPORT KIDNEY TRANSPORTER SYSTEM
• Generic Name: KIDNEY TRANSPORTER SYSTEM
• Product Code: KDN
• Date Received: 2019-09-13
• Returned To Mfg: 2019-04-15
• Model Number: LKT100P, LKT200
• Catalog Number: LKT100P, LKT200
• Lot Number: 73588264
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORGAN RECOVERY SYSTEMS. INC.
• Manufacturer Address: 1 PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-13