MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Catalog Number 050-87212

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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.A companion sample from one of the identified lots was returned from controlled stock for investigation, simulation use tested, and no defects were noted.In addition, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis (pd) patient reported following his treatment he found fluid had leaked inside the cassette door.He attempted to do another treatment with new supplies when the cycler alarmed.He was advised to discontinue the current treatment and to contact his pd nurse.The set was discarded.During follow up the patient's contact reported he had contacted his pd nurse and no antibiotics were prescribed.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; mike allen 1331 parque industrial; reynosa, tamaulipas CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346831
• MDR Text Key: 35995168
• Report Number: 8030665-2015-00614
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• 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
• Report Date: 12/30/2015

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Other Device ID Number: 00840861100736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/30/2015
• 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