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

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

Patient Problem Uremia (2188)

Event Date 06/01/2014

Event Type  Injury  

Event Description

A spouse reported that a patient was hospitalized on an unknown date in (b)(6) 2014, due to uremia.This spouse stated that the patient did not dialyze on the day of the admission.As of (b)(6) 2014, the patient was discharged from the hospital, the uremia resolved, and the patient continues to use continuous cycler- assisted peritoneal dialysis (ccpd) therapy without any further issues.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has requested medical records and investigations are pending.A supplemental medwatch report will be submitted when medical records are received.The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4017081
• MDR Text Key: 4691669
• Report Number: 2937457-2014-01763
• 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: Other,Health Professional,User Facility
• Type of Report: Initial
• Report Date: 06/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• 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
• Date Manufacturer Received: 06/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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; DELFLEX PD SOLUTION
• Patient Outcome(s): Hospitalization