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

Device Problems Device Alarm System (1012); Overfill (2404); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

A continuous cycling peritoneal dialysis (ccpd) rn called tech support and requested a replacement cycler for the patient.There have been many drain alarms with slow drains.She added that the cycler was very noisy.On review of treatment data obtained from the cycler, a large drain 4 was discovered: 1906ml.There was no complaint of discomfort or pain.Treatment data provided below: attempts to contact the patient's reporting pdrn have been unsuccessful.No additional event info is available at this time.The reported drain volume of 1906ml was 191% over the expected drain volume which resulted in a reportable device malfunction.

Manufacturer Narrative

A review of the info available was performed by the post market surveillance dept.A large intra-peritoneal drain 4 occurred with an undetermined cause.There was no adverse event reported with this large drain volume.A supplemental medwatch report will be submitted upon completion of the device investigation.

• Brand Name: LIBERTY CYCLER
• Type of Device: FKX
• 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: 4711604
• MDR Text Key: 5662553
• Report Number: 2937457-2015-00531
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2009
• 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: FRESENIUS PD SOLUTION; LIBERTY CYCLER SET,