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

Device Problems Overfill (2404); Device Sensing Problem (2917)

Patient Problem Discomfort (2330)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient called technical support to report a sensor alarm and that she was feeling very full and it hurt to walk around.Technical support assisted her with a drain and she felt much better.She mentioned that this has happened before.A review of the treatment data from (b)(6) 2014 indicated a large drain 5 volume.Treatment data provided below: drain 0: 18ml: fill 1: 2398ml drain 1: 2600 ml; fill 2: 2407 ml drain 2: 2594 ml; fill 3: 2407ml drain 3: 2602ml; fill 4: 2401ml drain 4: 2610ml; fill 5: 2407ml drain 5: 5252ml; fill 6: 48ml.Upon follow up contact with the patient's peritoneal dialysis rn (pdrn), she confirmed that the patient did have a large drain volume.She added that there was no serious injury or need for medical intervention as a result of this event.The patient continues with the ccpd program.The reported drain volume of 5252ml was 219% over the expected drain volume which resulted in a reportable device malfunction.

Manufacturer Narrative

A review of the information available was performed by the post market surveillance department.A large intra-peritoneal drain 5 occured with an undetermined cause.There was no adverse event associated with this reported large drain volume.The actual device was returned to the manufacturer for physical evaluation and 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: 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: jerry succuro, ccht, ma ; 920 winter st; waltham, MA 02451-1457 ; 7816970376
• MDR Report Key: 4349562
• MDR Text Key: 5205738
• Report Number: 2937457-2014-03407
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Date Manufacturer Received: 11/19/2014
• Date Device Manufactured: 01/01/2010
• 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 SET, FRESENIUS PD SOLUTION