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	06/24/2019
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 5 of their pd treatment.The patient reported receiving a volume error alarm prior to the leak and the treatment was cancelled.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¿s pdrn stated that the patient is not trained on performing stat drains or manual peritoneal dialysis therapy as the patient is unable to do continuous ambulatory peritoneal dialysis (capd) and relies on the patient¿s son to complete treatment.The pdrn confirmed that the patient has received the replacement cycler and continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.Further follow up with the patient confirmed that the cassette 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
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.The reported volume error alarm was confirmed.The reported fluid leak was not confirmed.An external visual inspection was performed on the cycler with no physical damage noted.There were no indications of dried fluid inside the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The teach pump test passed.The accelerated stress test (ast) failed.Failure due to grinding motor b and weak motor a.There were no fluid leaks in the test cassette during the ast test.The internal, visual inspection found indications of brown hp filters in the pump assembly.The cycler tested positive for glucose.An internal visual inspection identified evidence of dried fluid beneath the mushroom heads of pump a and b and 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 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: 8757606
• Report Number: 2937457-2019-02060
• Device Sequence Number: 1591410
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/09/2019

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: 07/10/2019
• Device Age: MO
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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 CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 56 YR
• Patient Weight: 100