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

Catalog Number 050-87212

Device Problem Leak/Splash (1354)

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

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis registered nurse called technical services and stated she was training a patient on the liberty cycler.At the end of treatment on step 9 patient¿s nurse was removing the cassette and fluid leaked all over the inside and outside of the liberty cycler when they opened the cassette door.The set was not made available for evaluation.During follow-up with patient¿s nurse she stated the patient was feeling well following the alleged fluid leak event.There was no report of patient encountering an adverse event as a result of the alleged fluid leak event.Additional patient demographic information was requested but not received at the time of this report.

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 there 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.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 6214182
• MDR Text Key: 63613105
• Report Number: 8030665-2016-00645
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 050-87212
• Device Lot Number: 16DR08102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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
• Patient Age: 56 YR
• Patient Weight: 62