MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY PDX CYCLER; 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	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be submitted upon device evaluation.
Event or Problem Description
A peritoneal dialysis patient's contact reported a supply bag alarm during dwell 2 of 5.The alarm could not be cleared and the treatment was discontinued.When removing the set the patient found fluid leaking.The source of the leak could not be identified.The cycler was replaced.The contact was advised to contact the patient's nurse nurse.During follow up the patient's nurse reported the patient did not have an adverse event associated with the leak.No antibiotics were prescribed.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.The internal inspection noted evidence of dried fluid within the cassette compartment.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.The cause of the dried fluid could not be determined.A simulated therapy was initiated and completed on the cycler without complication.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIBERTY PDX CYCLER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7210562
• Report Number: 2937457-2018-00222
• Device Sequence Number: 1022464
• 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: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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: 02/26/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 03/30/2018
• 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: LIBERTY PDX, INTEGRATED SET; PD FLUID
• Patient Age: 83 YR
• Patient Weight: 82