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

Model Number LIB

Device Problem Insufficient Information (3190)

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

Event Date 11/25/2012

Event Type  Injury  

Event Description

During call to technical service, the patient reported that he needed to be seen in the emergency room for abdominal pain.A follow up call was placed to his pd nurse and she reported that the patient had been hospitalized for peritonitis.

Manufacturer Narrative

Review of medical records: there was no report of a cycler or other product malfunction that could have caused the peritonitis event.There is no contact between dialysis solution and cycler which would cause an infection.There was no report of a fluid leak.Per pd nurse, she does not believe the peritonitis event was caused by the use of the cycler.Peritonitis is a known complication of peritoneal dialysis, usually caused by a break in the sterile field or aseptic technique.There is no history of fluid leaks, cassette breaks, or device malfunction.The actual device was returned to the manufacturer for physical evaluation or determined to be functioning according to product specifications.Further evaluation found no device malfunctions that would have caused the reported event.A batch record review was conducted and confirmed there were no deviation or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.

• Brand Name: LIBERY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 820winter street; waltham MA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999000
• MDR Report Key: 4308969
• MDR Text Key: 5132556
• Report Number: 2937457-2014-03313
• 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: Consumer,Health Professional
• Type of Report: Initial
• Report Date: 11/25/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: RTLR 180111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2013
• Initial Date Manufacturer Received: 11/25/2012
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 110