MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87212
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.
Event or Problem Description
A peritoneal dialysis patient reported that the cycler displayed the patient line is blocked message.The patient confirmed that all clamps were open and there was no kinks, air bubbles or fibrin in the tubing.The patient noticed that the blue pin of the connecter had been pushed in.The patient swapped out the connector for a new one.Once the patient pressed ok, it was noted that fluid was leaking from the connector.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
A peritoneal dialysis patient reported that the cycler displayed the patient line is blocked message.The patient confirmed that all clamps were open and there was no kinks, air bubbles or fibrin in the tubing.The patient noticed that the blue pin of the connecter had been pushed in.The patient swapped out the connector for a new one.Once the patient pressed ok, it was noted that fluid was leaking from the connector.

• Brand Name: LIBERTY CYCLER SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 6866776
• Report Number: 8030665-2017-00695
• Device Sequence Number: 1227647
• Product Code: FKX
• UDI-Device Identifier: 00840861100804
• UDI-Public: 00840861100804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Event Location: Home
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1