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

Model Number LIB

Device Problem Mechanical Problem (1384)

Patient Problem Peritonitis (2252)

Event Date 02/21/2012

Event Type  Injury  

Event Description

A pt called fresenius tech support regarding a m01-13 system error in setup.He stated that this had been happening for the past five days.The pt stated he has peritonitis and feels that receiving this and having to reset up the cycler may have contributed to it.

Manufacturer Narrative

A product investigation was completed on the returned cycler, to verify reported symptoms.There were no visual indications of a fluid leak in the device.Simulated treatment was done and m01-21-stalled at a state for a long time (warning) alarm occurred during fill 1.Balloon valve 6 was failing intermittently.There was debris near the valve's opening that prevented the valve from closing completely thus causing the leak.Subsequently, system air leak testing allowed the debris to pass thus correcting the m01.21 alarm.No other alarm or failure occurred.The cycler passed all functional tests.The reported symptom lz58-m01 system error alarm/warning could not be duplicated or verified.A review of the device history records was performed.There were no unexpected variances, or adjustments, or comments noted in the device documentation.A review was performed by the post market clinical dept.Per the pharmacovigilance physician there is no contact between the dialysis solution and the cycler which would cause an infection.There was no report of a fluid leak.Peritonitis in a pt undergoing peritoneal dialysis is most often due to contamination with pathogenic skin bacteria, or touch contamination.Patients undergoing peritoneal dialysis have the option of doing treatments manually.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: FRESENIUS LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS 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 ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4059104
• MDR Text Key: 20297132
• Report Number: 2937457-2014-02215
• 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
• Type of Report: Initial
• Report Date: 03/03/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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 Returned to Manufacturer: 03/13/2012
• Date Manufacturer Received: 03/03/2012
• 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