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

Model Number LIB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Uremia (2188)

Event Date 07/23/2011

Event Type  Injury  

Event Description

The peritoneal dialysis (pd) pt reported drain complications during drain 0 and she was experiencing shortness of breath on the liberty cycler.The pt stated that she recently had an abdominal surgery and had missed a few treatments before the surgery.The pt ended treatment and was transferred to the hosp.During a f/u call, the pt stated she was hospitalized for "being puffy and uremic." the pd nurse stated the pt was also experiencing chest pain.

Manufacturer Narrative

A clinical investigation was performed.During a f/u call, the pd nurse stated that the pt's symptoms and hospitalization were caused by the abdominal surgery and not due to the cycler.The pt was completing hemodialysis treatment until their abdomen heals.Per the fms associate director, pd nurse provided info related to the sequence of events and the historical timeline and present a pt who was hospitalized due to abdominal surgery and not due to the cycler use.The actual device was not returned for eval and therefore the reported event cannot be confirmed or replicated in field testing.The reported event could not be confirmed.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): FRESENIUS MEDICAL CARE NORTH AMERICA; 404 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4059106
• MDR Text Key: 4862761
• Report Number: 2937457-2014-02213
• 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: 07/24/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2011
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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