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

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 10/14/2013

Event Type  Injury  

Event Description

During review of medical records, it was discovered that patient was hospitalized for peritonitis from (b)(6) 2013 through (b)(6) 2013.

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.Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted there is no documentation of treatment modality for this event.There is no documentation in the medical record that indicates a causal relationship between the liberty cycler and bacterial peritonitis.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: LIBERTY CYCLER
• Type of Device: FKX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4369746
• MDR Text Key: 17575535
• Report Number: 2937457-2014-03507
• 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,Health Professional,User Facility
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• 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: 11/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2010
• 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 SET,; DELFLEX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 70