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

Model Number (RTLR) 180111

Device Problem Overfill (2404)

Patient Problems Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation and the complaint is not confirmed.There were no indications of dried fluid within the cassette compartment underneath the mushroom heads.There are no burrs or sharps inside the cassette door that may have punctured a cassette membrane.The heater tray/scale was not obstructed.Two simulated treatments were performed and completed without any alarms or problems occurring.A simulated treatment was performed in which the amount of fluid delivered to a pseudo patient bag during each fill phase was weighed.The weighed fluid volumes were compared against the programmed fill value, and the weighed volumes for each fill phase were determined to be within expected tolerance for the liberty cycler.The simulated treatment was performed and completed without any problems occurring.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.Medical records reveal upon admission, the patient had a disorder of the peritoneal dialysis catheter.Patient stated he had poor or no draining when supine and fair draining with sitting.Furthermore, the physician documented the patient was in significant volume overload related to malfunctioning or inadequate peritoneal dialysis.Medical records do not contain dialysis treatment for review.Medical records reveal that the patient had inadequate peritoneal dialysis flow related to the peritoneal dialysis catheter as evidenced by physician notes and patient's admission that his draining was positional.There was no documentation in the medical record that indicates a causal relationship between the patient liberty cycler and patient's hypertensive urgency.It should be noted that patients are expected and trained to perform manual exchanges at home if the liberty cycler malfunctions and medical records reveal that manual exchanges were successfully performed in the hospital.There was no documentation in the medical record that indicates a causal relationship between the patient's peritoneal dialysis solution and patient's hypertensive urgency.

Event Description

A peritoneal dialysis patient's nurse called in to request a cycler replacement due to the cycler "overfilling" the patient.During follow-up the nurse stated the patient called her on (b)(6) 2015 about a large negative uf and that he felt full.The patient reported that the cycler was not draining him all the way.After the patient did his treatment tuesday night and wednesday afternoon he called complaining of shortness of breath and chest pain.The patient's blood pressure was around 240/120.In two days the patient's weight increased from (b)(6).The patient went to the emergency room and was admitted for chest pain and hypertensive emergency.Medical records received from the clinic showed.Patient is a (b)(6) male who presented to the emergency room for a complaint of high blood pressure, chest pressure and abdominal tightness.Patient had a blood pressure earlier that day off greater than 240/120.In addition, the patient stated he had a 6kg weight gain over the previous 2 days.In the emergency room the patient's blood pressure was difficult to control with persistent blood pressures greater than 200's despite being given clonidine, lasix (intravenous), metolazone, metoprolol, minoxidil and labetalol.Patient was diagnosed with fluid overload, acute renal failure and hypertensive urgency and admitted the following day.Overall, the patient's hospital course was fairly unremarkable.Patient's medication regimen was adjusted and patient was placed on aspirin regimen.Patient was discharged five days later.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346745
• MDR Text Key: 35242804
• Report Number: 2937457-2015-01773
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: (RTLR) 180111
• Device Catalogue Number: LC001309
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention