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

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

Patient Problem Dehydration (1807)

Event Date 06/03/2014

Event Type  Injury  

Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market surveillance department has requested medical records and investigation are pending.The device was not returned to the manufacturer for analysis.A supplemental report will be submitted upon final review of medical records by the post market clinical and completion of the plant investigation.

Event Description

A nurse reported that a pt was admitted to the hospital on (b)(6) 2014 due to dehydration.The sample was discarded and is not available for return.The lot numbers are unk.The nurse stated the pt is educated on how to bypass cycler settings and perform manual treatments if needed, and no peritoneal dialysis treatments were missed.As of (b)(6) 2014, the pt continues to use continuous cycler-assisted peritoneal dialysis (ccpd) therapy without any further issues.

• 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 02451-1457 ; 7816999000
• MDR Report Key: 3950134
• MDR Text Key: 16586217
• Report Number: 2937457-2014-01425
• 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: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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
• Distributor Facility Aware Date: 06/11/2014
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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 SOLUTIONS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 91