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

Model Number	180237
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
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 (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler during fill 1 of their pd treatment.The patient reported receiving an air detected in cassette alarm during drain 0 of 6 of treatment 10 times and the patient reported that they received a m83 pump a vs.B volume alarm during fill 1.The cycler was rebooted and treatment was cancelled.The patient reported that they bypassed from drain 0 to fill 1.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient stated that they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that they were able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The patient confirmed that the leak was discovered in fill 1 after cancelling treatment.The liberty pdx, integrated set 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 Manufacturer Narrative
Additional information: d10, h3 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.There were visual indications of fluid found within the cassette compartment.There were no visual indications of particulates found within the cassette compartment.The simulated treatment post-accelerated stress test 2-hour 15-minute 8500 ml test passed.No fluid leaks were found in the test cassette during treatment.The cycler underwent and passed a patient sensor check.An internal visual inspection identified evidence of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.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: LIBERTY PDX CYCLER ASSY (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: 10088292
• Report Number: 2937457-2020-00930
• Device Sequence Number: 11494163
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 180237
• Device Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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.; LIBERTY PDX, INTEGRATED SET.
• Patient Age: 25 YR
• Patient Weight: 72