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

Catalog Number RTLR180111

Device Problem Insufficient Information (3190)

Patient Problem Chest Pain (1776)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient initially reported that he was in the hospital for few days due to "personal concerns".F/u was made with the pt's peritoneal dialysis registered nurse (pdrn) who indicated the pt was performing treatment and started to have chest pains.The pt was subsequently hospitalized for cardiac bypass.No further info was provided.

Manufacturer Narrative

Sections have been updated to reflect additional information received for this reported event.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.Device history review was performed and found no non-conformance reports or other abnormalities during the assembly of this lot.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC.; 4040 nelson ave.; concord CM 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5353184
• MDR Text Key: 35515335
• Report Number: 2937457-2016-00009
• 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,health professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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; Required Intervention