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	07/22/2021
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
A peritoneal dialysis registered nurse (pdrn) reported that a fluid leak was discovered during peritoneal dialysis (pd) patient¿s treatment.The fluid was discovered in the pump module area.The pdrn reported receiving air detected in cassette alarms prior to discovering the fluid leak.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The pdrn was advised to discontinue the use of their cycler.A new cycler was issued to the clinic.Upon follow up, the pdrn confirmed the reported event occurred during treatment.The pdrn stated they received multiple air detected in cassette alarms during an unknown phases of treatment.Upon checking the cassette door after finishing the treatment there was fluid leaking out all over the door and there was fluid leaking from the external of the cassette.The pdrn confirmed that there were no other fluid leaks observed.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment on the day of the reported event.The clinic is scheduled to receive a new cycler.The old cycler is scheduled to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported that a fluid leak was discovered during peritoneal dialysis (pd) patient¿s treatment.The fluid was discovered in the pump module area.The pdrn reported receiving air detected in cassette alarms prior to discovering the fluid leak.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The pdrn was advised to discontinue the use of their cycler.A new cycler was issued to the clinic.Upon follow up, the pdrn confirmed the reported event occurred during treatment.The pdrn stated they received multiple air detected in cassette alarms during an unknown phases of treatment.Upon checking the cassette door after finishing the treatment there was fluid leaking out all over the door and there was fluid leaking from the external of the cassette.The pdrn confirmed that there were no other fluid leaks observed.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment on the day of the reported event.The clinic is scheduled to receive a new cycler.The old cycler is scheduled to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer.A visual inspection of the returned cycler exterior showed that the front panel bezel gasket was drooping approximately.5 inches over the center of the front panel overlay.This does not obstruct the view or the functionality of the touch screen.There were no particulates within the cassette area.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.During a simulated treatment setup attempt, an m01-21 stalled at a state machine for a long time warning.The cause of the fault was due to a tear in the pump door air bag.After replacing the air bag, a simulated treatment post-ast 2-hour 15 min 8500 ml test was performed and completed without failures.There were no fluid leaks found in the test cassette.The cycler underwent and passed a system air leak test, valve actuation test, and a patient sensor calibration check.The internal inspection of the cycler showed that there were visual indications of dried fluid spots on the bottom cover within the recess underneath the pump assembly.There were indications of dried fluid on the bottom cover between the front panel assembly and the pump assembly.The cause of the observed dried fluid could not be determined.The mushroom head check passed.A review of the device manufacturing records was conducted and 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, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported that a fluid leak was discovered during peritoneal dialysis (pd) patient¿s treatment.The fluid was discovered in the pump module area.The pdrn reported receiving air detected in cassette alarms prior to discovering the fluid leak.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The pdrn was advised to discontinue the use of their cycler.A new cycler was issued to the clinic.Upon follow up, the pdrn confirmed the reported event occurred during treatment.The pdrn stated they received multiple air detected in cassette alarms during an unknown phases of treatment.Upon checking the cassette door after finishing the treatment there was fluid leaking out all over the door and there was fluid leaking from the external of the cassette.The pdrn confirmed that there were no other fluid leaks observed.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment on the day of the reported event.The clinic is scheduled to receive a new cycler.The old cycler is scheduled to be returned to the manufacturer for physical evaluation.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12240115
• Report Number: 2937457-2021-01573
• Device Sequence Number: 11714254
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171652
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

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: Health Professional
• 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
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 04/05/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/16/2021; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2010
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Sex: Male