MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Model Number LIB

Device Problem Failure to Cycle (1142)

Patient Problems Chest Pain (1776); Peritonitis (2252)

Event Date 07/05/2011

Event Type  Injury  

Event Description

A peritoneal dialysis patient's wife called fresenius technical support regarding many drain complication alarms and an m31 air cassette alarm occuring last night.The patient was able to complete treatment.She opened the door to remove the cassette and noticed a lot of moisture on the pump as well as the cassette.During a follow-up call, the pd nurse stated that the patient went to the hospital for severe peritonitis and chest pain.Pd treatment was discontinued and the pd catheter was removed.

Manufacturer Narrative

A product investigation was performed for this device.A visual inspection confirmed there was dried fluid inside the cassette compartment and underneath the mushroom heads.During a stimulated treatment the reported drain complication alarms were verified, due to fluid in the pneumatic system.The device passed the mushroom head inspections.The leak was contributed to the cassette.A device history record review was performed for this device.There was no unexpected variances, or adjustments or comments noted in the device records.A search in the complaint tracking system listed no other drain complications, m31 air in the cassette, or fluid leak complaints for this device.A review was performed by the post market clinical department.Per the pharmacovigilance physician the event of peritonitis is unlikely related to the liberty cycler machine.At the time of the event there were no further fluid leaks or any other machine malfunction.Peritonitis in a patient undergoing peritoneal dialysis is most often due to contamination with pathogenic skin bacteria resulting form touch contamination or catheter related infection.There was also a complaint of chest pain but sufficient information, medical records and treatment sheets were not available for review.It is reported the patient is currently on hemodialysis and is doing well.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): WALNUT CREEK PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4072091
• MDR Text Key: 4854447
• Report Number: 2937457-2014-02419
• 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: Other,Consumer
• Type of Report: Initial
• Report Date: 07/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: 180020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/05/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other