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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGAN RECOVERY SYSTEMS, INC. LIFEPORT KIDNEY TRANSPORTER SYSTEM; PERFUSION CIRCUIT
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ORGAN RECOVERY SYSTEMS, INC. LIFEPORT KIDNEY TRANSPORTER SYSTEM; PERFUSION CIRCUIT Back to Search Results
Model Number LKT200
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2019
Event Type  malfunction  
Manufacturer Narrative
The device has no contact with patient.
 
Event Description
On (b)(6) 2019, organ recovery systems (ors) received a customer complaint that the lkt200 leaked fluid.
 
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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
Manufacturer (Section G)
ORGAN RECOVERY SYSTEMS, INC.
1 pierce place
suite 475w
itasca IL 60143
Manufacturer Contact
roxanne geary
1 pierce place
suite 475w
itasca, IL 60143
8478242436
MDR Report Key9349319
MDR Text Key195405343
Report Number3004068499-2019-00002
Device Sequence Number1
Product Code KDN
UDI-Device Identifier00815045020032
UDI-Public00815045020032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021362
Number of Events Reported1
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 11/20/2019
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 Date06/13/2021
Device Model NumberLKT200
Device Catalogue NumberLKT200
Device Lot Number76657831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2019
Initial Date FDA Received11/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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