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 Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - the device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were 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 (pd) patient¿s wife called technical services and stated during drain 7 the cycler received air detected in cassette warning message.The patient was unable to get past the warning message and canceled the treatment.When patient¿s wife removed the cassette from the liberty cycler, fluid was leaking out of the cassette door.Patient stated he noticed a tear in the cassette.Patient performed continuous ambulatory peritoneal dialysis to complete the treatment.The set was not made available for evaluation at the time of this report.During follow-up with the patient¿s nurse she stated the patient continued the treatment on continuous cycler-assisted peritoneal dialysis with replacement cycler without further issue.There was no report of patient experiencing any serious injury or missed treatments as a result of the alleged event.

• 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: 6234384
• MDR Text Key: 64217339
• Report Number: 8030665-2017-00012
• 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,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 12/15/2016
• 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
• Treatment: LIBERTY CYCLER; PD FLUID
• Patient Age: 65 YR
• Patient Weight: 114