MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Overheating of Device (1437)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

The cycler was returned for evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.There were indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.Turning on the cycler, the display screen was improperly dim.A simulated treatment was performed and completed without any failures or problems occurring.There were no fluid leaks in the test cassette during the treatment test.The system air leak test passed.The valve actuation test passed.The patient sensor calibration check passed.The load cell verification was within tolerance.Mushroom head check passed.Troubleshooting of the dim front panel display and an internal inspection of the cycler unit showed that, on the front panel assembly, the inductor coil on the inverter board was burn damaged due to the coil wirings overheating.After replacing the damaged inverter board, the display was normally bright.There was dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported the cycler alarmed for scale reading errors, drain complications, and air detected in the cassette.The alarms could not be cleared and treatment was discontinued.While removing the set the patient found fluid leaking.The cycler was replaced.During follow up the patient's nurse reported there was no adverse event.During evaluation on 03/27/2018 the cycler had a dim display and upon further evaluation the inductor coil on the inverter board was burn damaged due to the coil wirings overheating.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7387038
• MDR Text Key: 104034406
• Report Number: 2937457-2018-00923
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/30/2018

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: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 136