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

Device Problems No Display/Image (1183); Device Inoperable (1663); Noise, Audible (3273)

Patient Problem Dyspnea (1816)

Event Date 02/24/2015

Event Type  Injury  

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient's registered nurse (rn) called technical support requesting a replacement cycler.She stated that when she turned on the device, it made a frying sound and the screen was blank.The pt was then advised to complete manual exchanges while waiting for the replacement.Upon follow up contact with the patient's peritoneal dialysis rn (pdrn), she stated that the pt was admitted to the hosp on (b)(6) 2015 for shortness of breath and fluid overload due to the inability to use the cycler.The pt was discharged from the hosp on (b)(6) 2015 in stable condition and pt continues with the ccpd program.Pt med records have been requested.

Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event.The pt has been trained and was advised by the pdrn to complete manual exchanges while waiting for the replacement cycler.The post market surveillance dep requested the patient's med records.A supplemental medwatch report will be submitted upon completion of the clinical and device investigations.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer Contact: jerry succuro, ccht, ma ; 920 winter st; waltham, MA 02451-1457 ; 7816970376
• MDR Report Key: 4634831
• MDR Text Key: 5572505
• Report Number: 2937457-2015-00394
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 100