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

Model Number	180237
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.There were visual indications of dried fluid within the cassette compartment, however; there were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The valve actuation test failed.The failure was due to balloon valve leaking causing the drain line unable to be detected and causing the compressor to continually run causing the audible sound.A known good valve was installed to continue testing.The valve actuation and system air leak tests passed.During internal visual inspection of the returned cycler revealed an internal short on the bottom of the back plane board.The internal short found was unrelated to the reported issue.The internal visual inspection also revealed there were visual indications of dried fluid underneath the pump assembly on the bottom cover.The cause of the dried fluid could not be determined.The cycler tested positive for glucose.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.The cycler was refurbished following the evaluation.
Event or Problem Description
A peritoneal dialysis (pd) patient contacted fresenius technical support to report the liberty pdx cycler alarmed with a dl drain line is blocked message and balloon valve leak warning during step 2 of setup.The cycler also produced a noise like a motor running during setup.The fresenius technical support representative issued a replacement cycler and advised the patient to discontinue using the machine.The patient was advised to inform the peritoneal dialysis registered nurse (pdrn) of the cycler replacement.Upon follow up with the patient, it was confirmed that no patient adverse effects were experienced and no medical intervention was required.The patient was able to complete treatment via manual exchanges.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board had an internal short.

• 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: 9787546
• Report Number: 2937457-2020-00432
• Device Sequence Number: 2649700
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/10/2020
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1