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

Device Problem Invalid Sensing (2293)

Patient Problem Hernia (2240)

Event Date 11/01/2014

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) pt was reported as having been hospitalized and diagnosed with a hernia in (b)(6) 2014.The pt had been subsequently discharged and able to continue with cycler-based treatment.Medical records have been requested.

Manufacturer Narrative

A supplemental report will be submitted upon completion of plant's investigation.

• 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 ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4364459
• MDR Text Key: 15324403
• Report Number: 2937457-2014-03484
• 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,User Facility
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 11/20/2014
• 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
• Treatment: LIBERTY CYCLER CASSETTE; DELFLEX PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention