MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 09/08/2014

Event Type  Injury  

Event Description

It was reported by the clinic that the pt has confirmed peritonitis (enterobacter) and is receiving antibiotic treatment and did not require hospitalization.The cause of the peritonitis is unk.The pt has continued with regular peritoneal dialysis treatments.A request for additional info was made.

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 re[pt will be submitted upon final review of medical records by post market clinical and completion of the pt's investigation.This report is related to two other reports for the same event.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; concord CA
• Manufacturer (Section G): CONCORD, RESENIUS MEDICAL CARE; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: corie vazquez, mgr ; 920 winter st; waltham, MA 02451-1457 ; 7816999017
• MDR Report Key: 4172594
• MDR Text Key: 5103200
• Report Number: 2937457-2014-02853
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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
• Treatment: LIBERTY CYCLER TUBING SET; DELFLEX SOLUTION
• Patient Outcome(s): Required Intervention