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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Weakness (2145)

Event Date 05/16/2014

Event Type  Injury  

Event Description

During follow up of unrelated issue, a nurse reported the patient had been hospitalized for a "heart rate issue" occurring independent of dialysis and without allegation of device malfunction.Prior to the hospitalization the patient had been on peritoneal dialysis (pd) for about 3 years and had a short trial of hemodialysis (hd) this year (date unknown).He developed symptoms consistent with peritonitis at this time including draining approximately 2l of dark, cloudy effluent.He did not have any pd solution in the peritoneum at this time because he was using hd.He was treated for peritonitis.He complained of dyspnea on exertion mostly from moving from chair to bed and used oxygen during sleep.He had occasional physical therapy for un-stated reason.On (b)(6) 2014, the patient was admitted to the hospital with complaints of chronic fatigue, generalized weakness, and dyspnea on exertion with reports of feeling "awful" for the last 8 months with (b)(6) lb weight loss.According to the medical record: the patient was diagnosed with hypokalemia (k+ 2.9), weakness of a chronic nature likely from deconditioning and ascites of a chronic nature.Peritonitis was ruled out during the admission.Ct imaging of the liver showed moderate ascites/splenomegaly consistent with cirrhosis and portal hypertension along with elevated transaminases: alt 87/ast 83.He denied significant use of alcohol.He was noted to have orthostatic blood pressure changes form chronicity suspected due to autonomic dysfunction in the setting of diabetes mellitus, cardiac.He did not look hypovolemic on exam.The patient's health overall sounded much poorer than perceived by the patient and spouse.He was discharged home on (b)(6) 2014 and continued on pd.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has reviewed medical records and the clinical investigation reveals the following: based on the 12 pages of medical records information and a review of the documentation of the fresenius pilgrim system, it appears that from (b)(6) 2014 through (b)(6) 2014, the patient was hospitalized as he was symptomatic for chronic fatigue, electrolyte disturbances, microcytic anemia, chronic obstructive pulmonary disease, ascites and ultrafiltration with his peritoneal dialysis.The patient was not connected to the liberty cycler at the time of diagnosis.The patient's pd nurse stated that he was hospitalized due to an irregular cardiac rhythm; however, there is no documentation in the patient' record supporting that diagnosis for this hospitalization.This event has been reported as serious injury, although it is undetermined if there is a reasonable causal relationship between the product and the event.The liberty cycler was not returned for investigation, and the patient allegedly uses the same cycler.This event is being filed as an mdr reportable serious injury to comply with our regulatory commitment to report any serious injury while using a fresenius device if the device investigation has not been completed.The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4067902
• MDR Text Key: 18935013
• Report Number: 2937457-2014-01968
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SEVELAMER; KCL; ALBUTEROL; LIBERTY CYCLER SET; LANTUS INSULIN; OXYGEN 2L VIA NC; FLORINEF; FRESENIUS PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 102