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

Catalog Number 050-87216

Device Problem Leak/Splash (1354)

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

Event Date 11/12/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A supplemental report will be submitted upon completion of plant¿s investigation.

Event Description

A peritoneal dialysis patient called technical services during drain 4 of 5 and had received air detected in cassette message on the liberty cycler.The patient canceled treatment and removed the cassette from the cycler.During this process the patient observed fluid ¿all over¿.The set was not made available for evaluation.Further details of event were requested but not received at the time of this report.No adverse event reported at this time.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.The entire lot has been sold and distributed.Batch record for the lot identified was reviewed and confirmed were no non-conformances and/or any associated rework during the manufacturing process.In addition, the device record review confirmed result of in-progress, and final qc testing were found with acceptable results.

Event Description

A peritoneal dialysis patient called technical services during drain 4 of 5 and had received air detected in cassette message on the liberty cycler.The patient canceled treatment and removed the cassette from the cycler.During this process the patient observed fluid ¿all over.¿ the set was not made available for evaluation.Further details of event were requested but not received at the time of this report.No adverse event reported at this time.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• 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: 6142865
• MDR Text Key: 61400930
• Report Number: 8030665-2016-00592
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 050-87216
• Device Lot Number: 16KR08036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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
• Treatment: LIBERTY CYCLER; PD FLUID