MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY SELECT CYCLER

Device Problems Thermal Decomposition of Device (1071); Overfill (2404); Device Operates Differently Than Expected (2913)

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

Event Date 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

It was reported that a peritoneal dialysis patient was not draining.Treatment data was provided.Treatment data was assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv) on (b)(6) 2018.The largest drain volume from this treatment occurred after treatment where 4500ml drained.This drain is 180% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.A 180% of fill volume 2500ml is 4500.Follow up with the patient¿s peritoneal dialysis nurse confirmed the patient did not experience any complications as a result of the event.The patient uses 2.5% delflex.The patient¿s prescription includes a last fill, followed by a manual drain.The patient has received the replacement cycler, no treatments were reported missed.

Manufacturer Narrative

Plant investigation: the reported complaint symptom (drain volume > 180% to 200% of fill volume) was not confirmed.A visual inspection of the returned cycler exterior showed no signs of physical damage.There were no indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.When turning on the cycler, the display screen was abnormally dim.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.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 load cell verification was within tolerance.Troubleshooting of the cycler and an internal inspection of the unit showed that, on the front panel assembly, the inductor coil on the inverter board was burn, damaged as the laminate insulation had melted, becoming discolored (black) due to the coil wirings overheating.After replacing the damaged inverter board, the display was normally bright.After replacing the damaged inverter board, a simulated treatment was performed and completed without failures.The internal inspection showed that there were dried fluid spots within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.Mushroom head check passed.Tested negative for glucose.The device history record did not reveal any issues or problems related to the reported symptom code(s).

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7540439
• MDR Text Key: 109234176
• Report Number: 2937457-2018-01437
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.5% DELFLEX PD SOLUTION; LIBERTY CYCLER SET