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

Model Number LKT100

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Device Displays Incorrect Message (2591)

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

Event Date 04/10/2019

Event Type  Injury  

Event Description

Lifeport kidney pump malfunction: the right kidney for organ donor (b)(6) was placed on the lifeport kidney pump on (b)(6) 2019.On (b)(6) 2019 at 1700 a red flashing error light was observed on the pump but no alarm sounding.The pump info was downloaded and it appeared that the pump stopped pumping at 1555.The kidney was taken off the pump, but when the cassette was opened, there was no visible fluid in the cassette.We do not know how long the kidney was not in cold solution storage and cold storage should be the backup mode for any pump failure.Therefore, the kidney was declined for transplant and resulted in a discard of the organ.Add'l info: upon further investigation of the pump, there was only about an inch of mps in the bottom of the cassette, the rest of the solution was under the ice bucket and coming out from the bottom of the machine.Once we identified the issue and took everything apart, we also flushed the cassettes to see if there were any leaks.We could not identify any leaks in the cassettes.We also tipped the machine on the side and found fluid coming out between the top and bottom of the pump.We called the lifeport perfusion hotline and they sent a form for us to fill out and instructed up to send the pump and cassette for further device investigation.The pump and cassettes were sent to lifeport for inspection (b)(6) 2019.This event was also reported to (b)(6) as a pt safety event (event #(b)(6)) on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: LIFEPORT KIDNEY PUMP
• Type of Device: SYSTEM, PERFUSION, KIDNEY
• Manufacturer (Section D): ORGAN RECOVERY SYSTEMS, INC.
• MDR Report Key: 8545362
• MDR Text Key: 143205224
• Report Number: MW5086095
• Device Sequence Number: 1
• Product Code: KDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LKT100
• Device Lot Number: 73588264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other