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

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 11/01/2014

Event Type  Injury  

Event Description

During review of medical records, it was found that "pt was admitted to hospital in (b)(6) 2014 with severe e.Coli peritonitis that was successfully treated".

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 clinical staff's assessment of the reported info and the plant's investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; walnut creek CA
• Manufacturer (Section G): FRESENIUS USA, INC.; 4040 nelson avenue; concord CM 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4790463
• MDR Text Key: 5802118
• Report Number: 2937457-2015-00962
• 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
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• 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
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET, PD SOLUTION
• Patient Outcome(s): Hospitalization