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

Catalog Number RTLR180111

Device Problem Device Alarm System (1012)

Patient Problem Hypervolemia (2664)

Event Date 09/13/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the clinical and manufacturer's device investigation.

Event Description

A continuous cycling peritoneal dialysis (ccpd) patient's caregiver called technical support, to request a replacement cycler due to continued/repeated cycler alarms.Upon follow up w/the patient's pd nurse, she stated that she was aware of the patient's continued cycler issues and the many replacement devices.As a result of the constant issues and the patient's inability to complete multiple treatments, he was hospitalized from (b)(6) 2015 for fluid overload.He was returned to the ccpd program.The patient's medical records were requested.

Manufacturer Narrative

Based on the 11 pages of medical records information, it appears that this (b)(6) male patient was admitted to the hospital on (b)(6) 2015, with chief complaints of cough, shortness of breath, and fever.A review of medical records showed the patient had complaints of technical difficulties with his cycler where several treatments were not completed due to cycler alarms, there is no documentation stating that continuous ambulatory peritoneal dialysis (capd) was performed, and the patient experienced an episode of fluid volume overload.During the admission on (b)(6) 2015, the patient was diagnosed with pneumonia and experienced rapid atrial fibrillation with rapid ventricular response, a diltiazem drip was initiated, and the patient was admitted to a telemetry unit.On (b)(6) 2015, the patient was discharged from the hospital to home, amiodarone 200mg daily and coumadin (warfarin) was prescribed, the patient is in stable condition, and the patient continues ccpd therapy.There is no documentation in the medical record supporting a possible association between the use of delflex pd solutions, the liberty cycler, and the events of fluid volume over load, atrial fibrillation, and pneumonia.The actual device was returned to the manufacturer for physical: external visual inspection showed no indications of dried fluid within the cassette compartment or underneath the mushroom heads.The exterior showed no signs of any physical damage.The heater tray/scale was not obstructed.A simulated treatment was performed using the received cycler, and there were no alarms or problems that occurred during testing.There were no fluid leaks in the test cassette during the treatment test.The valve actuation test and system air leak test passed.Internal inspection showed indications of dried fluid on the bottom cover between the front panel and the pump assembly.The cause of the encountered dried fluid could not be determined.The mushroom head check passed.A device manufacturing record review was conducted and confirmed there were no deviations 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.; concorsd CA 94520
• Manufacturer Contact: jerry succuro,ccht, ma ; 920 winter st.; waltham, MA 02451-1457 ; 7816970376
• MDR Report Key: 5147850
• MDR Text Key: 28317903
• Report Number: 2937457-2015-01497
• 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
• Type of Report: Followup
• Report Date: 09/13/2015

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
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 76