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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144); Electrolyte Imbalance (2196)

Event Date 01/06/2014

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse reported a patient was hospitalized.The patient was admitted for nausea and vomiting secondary to gastroparesis and treated with pyradone.He was also diagnosed with a urinary tract infection and treated with levaquin for 14 days.The patient was also found to have hypokalemia and hypomagnesemia and treated with supplements for both.The patient was found not to have diabetes, but glucose intolerance that might have caused the gastroparesis.

Manufacturer Narrative

A serious injury has occurred to a peritoneal dialysis patient following treatment with a cycler.Due to lack of info an mdr will be filed against the cycler while undergoing review by post market clinical department and manufacturing plant.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3677257
• MDR Text Key: 4255131
• Report Number: 2937457-2014-00265
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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 CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR