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

Model Number	180111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported that a peritoneal dialysis nurse (pdrn) discovered a fluid leak on the inside of the cassette door of a cycler after the patient completed their pd treatment.The pdrn reported receiving an m21-10 invalid sensor reading.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Upon follow up, the pdrn confirmed that the patient was able to complete peritoneal dialysis treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cycler was removed from service and subsequently replaced.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.The cycler was returned to the manufacturer for physical evaluation.Additional information was requested however to date has not been provided.
Additional Manufacturer Narrative
Additional information:d.9, h.3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.Although there was evidence of dried fluid present within the cassette compartment on the pump door and on the top cover.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were visual indications of particulates within the cassette area.A post accelerated stress test (ast) simulated treatment was performed.An m31 air detected in cassette alarm occurred during fill 2 of treatment.The cycler underwent and passed a system air leak test, valve actuation test, and patient sensor pressure verification.A second post- ast simulated treatment was performed and completed without any failures or problems.No fluid leaks in test cassette during test.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 observed dried fluid could not be determined.There was visual evidence of a clog in hp1, hp2 and hp3 filters.The filters were replaced.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.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
Event or Problem Description
It was reported that a peritoneal dialysis nurse (pdrn) discovered a fluid leak on the inside of the cassette door of a cycler after the patient completed their pd treatment.The pdrn reported receiving an m21-10 invalid sensor reading.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Upon follow up, the pdrn confirmed that the patient was able to complete peritoneal dialysis treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cycler was removed from service and subsequently replaced.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.The cycler was returned to the manufacturer for physical evaluation.Additional information was requested however to date has not been provided.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14111311
• Report Number: 0002937457-2022-00622
• Device Sequence Number: 5191224
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Sex: Unknown