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

Catalog Number	RTLR180237
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
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 after ending their pd treatment.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.Upon follow up, the peritoneal dialysis nurse (pdrn) stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete the peritoneal dialysis treatment before discovering the leak.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.
Additional Manufacturer Narrative
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, there were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.An (as-received) simulated treatment was performed and completed on the cycler with no issues noted.There were no fluid leaks in the test cassette during the simulated treatment.A pressure/vacuum test was performed and passed.A glucose test was performed and returned a positive result.An internal visual inspection identified evidence infestation in the unit.There were no indications of fluid or dried fluid underneath the pump assembly.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8004583
• Report Number: 2937457-2018-03199
• Device Sequence Number: 1302143
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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 Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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 CYCLER SET ; DELFLEX PD FLUID; LIBERTY PDX CYCLER SET
• Patient Age: 50 YR
• Patient Weight: 110