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	07/23/2021
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
It was reported that a registered nurse (rn) discovered a fluid leak from the cassette door of the cycler during step 9 after ending the patient¿s pd treatment.The rn reported receiving m31 air detected in cassette alarms during an unknown phase and cycle of treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The fluid leak did come in contact with the cycler and was discovered in the pump module area.Fluid was not discovered on the external of the cassette.The rn was advised to discontinue the use of their cycler.A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the rn stated the patient completed peritoneal dialysis treatment using another facility cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The facility has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The liberty cycler set used by the patient was discarded and is no longer available to be returned for physical evaluation by the manufacturer.The cycler is available to be picked up as scheduled to the manufacturer for physical evaluation.
Event or Problem Description
It was reported that a registered nurse (rn) discovered a fluid leak from the cassette door of the cycler during step 9 after ending the patient¿s pd treatment.The rn reported receiving m31 air detected in cassette alarms during an unknown phase and cycle of treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The fluid leak did come in contact with the cycler and was discovered in the pump module area.Fluid was not discovered on the external of the cassette.The rn was advised to discontinue the use of their cycler.A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the rn stated the patient completed peritoneal dialysis treatment using another facility cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The facility has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The liberty cycler set used by the patient was discarded and is no longer available to be returned for physical evaluation by the manufacturer.The cycler is available to be picked up as scheduled to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.There were visual indications of dried fluid within the cassette compartment on the pump.There were visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.An accelerated stress test (ast) was performed on the cycler and passed.There were no fluid leaks in the test cassette during the accelerated stress test.There were visual indications of dried fluid on the bottom cover underneath the pump assembly.The cause of the observed 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.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.

• 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
• MDR Report Key: 12225223
• Report Number: 2937457-2021-01552
• Device Sequence Number: 5061329
• 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: K123630
• 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 faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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
• Date Returned to Manufacturer: 09/02/2021
• Device Age: MO
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET