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

Catalog Number UNKNOWN- FMC CASSETTE

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for investigation.A supplemental report will be submitted if the device is returned.

Event Description

A peritoneal dialysis patient reported that the cycler displayed an air detected in cassette message.The patient confirmed that there is no air which can be seen in the patient line.The treatment was cancelled.When the patient removed the cassette, it was noted that there was fluid leaking inside the cassette door.Technical support advised to discontinue use and will replace the cycler.The patient will use manual treatment to complete.

Manufacturer Narrative

Additional verbiage not included in initial report: 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 Description

A peritoneal dialysis patient reported that the cycler displayed an air detected in cassette message.The patient confirmed that there is no air which can be seen in the patient line.The treatment was cancelled.When the patient removed the cassette, it was noted that there was fluid leaking inside the cassette door.Technical support advised to discontinue use and will replace the cycler.The patient will use manual treatment to complete.

• Brand Name: LIBERTY CYCLER SET
• Type of Device: 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6778573
• MDR Text Key: 82819381
• Report Number: 8030665-2017-00552
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Event Location: Home
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1