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

Catalog Number RTLR180111

Device Problem Device Alarm System (1012)

Patient Problem Peritonitis (2252)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the device manufacturer's investigation.

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient called technical support regarding drain complication alarms.Upon follow up with the patient's pd nurse, she confirmed the patient was admitted to the hospital for peritonitis as a result of aseptic technique violation.The patient had a history of cloudy effluent for a few days.She was discharged home with antibiotics in stable condition.Medical records requested.

Manufacturer Narrative

The actual 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 non-conformance during the manufacturing process.Product labeling, material and process controls were within specification.

• 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 ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5337974
• MDR Text Key: 34924740
• Report Number: 2937457-2015-01749
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: No Information
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2009
• 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; Required Intervention