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

Model Number	180111
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.There were visual indications of dried fluid within the cassette compartment.There was visual indication of particulates around the catch post area and within cassette compartment.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.Touch screen test failed when powering on the cycler the ok and stop push buttons illuminated, however the front panel display remained blank.It was identified that the cause for the blank screen was due to an internal short present transformer on the inverter board.A known good inverter board was installed and the display became fully operational.Encountered failure on touch pad for not responding when pressing the buttons.The function board was determined to cause the failure.Installed a known good function board, the touch pad responded.Removed function board at the completion of the investigation.There were visual indications of dried fluid found in between of the pump assembly and display assembly during internal inspection.There were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump during internal inspection.The cause of the dried fluid could not be determined.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.A device history record review was performed and verified that the results of the in progress and final quality control testing met all requirements.The reported issue was confirmed; the cause was determined to be an internal short on transformer on the inverter board.The cycler was refurbished following the evaluation.
Event or Problem Description
It was reported that the screen of a patient¿s liberty select cycler went blank during power up before their peritoneal dialysis (pd) treatment.The power cord was properly connected in both ends and cycler plugged directly into the wall outlet.The cycler was rebooted, the ok and stop keys lit up, however the screen remained blank.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Additional information requested but has not been obtained.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16195957
• Report Number: 0002937457-2023-00080
• Device Sequence Number: 17635055
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K181108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown