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

Catalog Number RTLR180111

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 04/23/2013

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.The record review confirmed the labeling, material, and process controls were within specification.There were no reported device malfunctions.Medical records have been requested and were not received.

Event Description

A peritoneal dialysis nurse reported that a patient had abdominal pain and hospitalized for peritonitis.

Manufacturer Narrative

Limited information was provided for this safety report.There is no allegation against any fresenius product in relation to the reported event.

Event Description

This peritoneal dialysis (pd) nurse stated that the episode of peritonitis was due to touch contamination, where the patient did not practice aseptic technique and broke the sterile field during treatment.During the admission, the peritonitis was treated with antimicrobial therapy via intraperitoneal (ip) route: drug name, dose, and frequency unknown.On an unknown date in (b)(6) 2013, the patient was discharged from the hospital, the event of peritonitis resolved, and the patient continued continuous peritoneal dialysis (ccpd) therapy.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 8006621237
• MDR Report Key: 5204002
• MDR Text Key: 30571855
• Report Number: 2937457-2015-01565
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention