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 11/30/2015

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's nurse called technical support requesting a replacement cycler due cycler alarms and the patient's admission to the hospital.Upon follow up with the patient's pd nurse, she confirms that the patient was admitted to the hospital for abdominal pain with a diagnosis of peritonitis.The patient had completed a manual exchange in an unfamiliar environment resulting in a break of aseptic technique.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-conformances 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: 5337975
• MDR Text Key: 34922145
• Report Number: 2937457-2015-01748
• 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
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2009
• 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