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

Model Number RTLR1801

Device Problems Inadequate Filtration Process (2308); Delivery System Issue, No Description (2664)

Patient Problems Atrial Fibrillation (1729); Congestive Heart Failure (1783); Dyspnea (1816); Urinary Tract Infection (2120); Hypervolemia (2664)

Event Date 06/11/2015

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported a pt was hospitalized on (b)(6) 2015 due to an urinary tract infection.During hospitalization, the pt was diagnosed with congestive heart failure (chf) with shortness of breath and hypervolemia with atrial fibrillation.The nurse stated chf was due to the pt's body not properly draining during dialysis.On (b)(6) 2015, the pt was discharged and the outcomes of both these events resolved.

Manufacturer Narrative

Preliminary review of medical records provided this pd pt with esrd was recently admitted to hospital for initiation of emergent hd since pd catheter was not draining.The pt was a kidney transplant recipient for many years and recently recommended on renal replacement therapy, pd, most likely as result of chronic allograft rejection.Atrial fibrillation (af) is most likely a result of hypervolemia, which was corrected following initiation of emergent hd and commencement of cardizem.The pt also has a previous history of af in (b)(6) 2014.Radiology results ((b)(6) 2015): mild cardiomegaly with central pulmonary vascular congestion and perihilar interstitial edema suggestive of cardiac insufficiency.Poor lung inflation with retrocardiac airspace disease that may reflect subsegmental pulmonary volume loss.

Manufacturer Narrative

Based on the 31 pages of medical records, it appears that on (b)(6) 2015, this pt was admitted into the hospital after poor dialysis catheter drainage.The pt presented with abdominal discomfort.She was admitted to have her peritoneal dialysis catheter revised and a tunnel catheter placed for hemodialysis.During her hospitalization, the pt experienced atrial fibrillation and pulmonary vascular congestion.This was pt's third episode of atrial fibrillation since (b)(6) 2014.An echocardiogram from (b)(6) 2014 showed a left atrial diameter of 4.3.Left ventricular end-systolic diameter is 4.2.There was concentric left ventricular hypertrophy with a mild left ventricular dysfunction.Ejection fraction was approx 45%.She had a grade 2 diastolic dysfunction with mild tricuspid regurgitation.According to the peritoneal dialysis registered nurse (pdrn), the pt was hospitalized due to a urinary tract infection.During hospitalization, the pt was found to have congestive heart failure due to her body not draining properly.The pdrn revealed the pt started peritoneal dialysis therapy in (b)(6) 2014.The peritoneal dialysis catheter is not a fresenius manufactured product.There was a plan for the pt temporary switched to hemodialysis to balance her chemistry.While at the hospital, it was determined to move this procedure up one week and perform the procedure.There was no documentation in the medical record that indicated there was a causal relationship between the pt's liberty cycler and the pt's poor drainage.There was no documentation in the medical record that showed a causal relationship between the pt's liberty cycler and the episode of atrial fibrillation.Medical records revealed the pt has a history of atrial fibrillation.Medical records did not indicate there was a causal relationship between the pt's liberty cycler and the pt's pulmonary vascular congestion.Medical record did not contain progress notes of dialysis treatment records for review.There was no documentation in the medical record that revealed type of dialysis used at time of atrial fibrillation or pulmonary vascular congestion.There was no documentation in the medical record that showed the pt had a urinary tract infection.

Event Description

Medical records indicated a (b)(6) female patient presented to the hospital on (b)(6) 2015 due to retaining fluid the patient felt uncomfortable with abdominal discomfort.She also had some shortness of breath secondary to her volume overload and increased abdominal girth.Blood pressure was 155/90, heart rate 82 and temperature 98.3 she performed her peritoneal dialysis the previous night and did not complete therapy the patient's initial treatment plan was to have a tunnel catheter inserted to start hemodialysis for a short period in an effort to get all her chemistry back to normal it was scheduled for the following week but, due to the non-functioning peritoneal dialysis catheter, the patient was admitted for placement of tunneled catheter and to have a revision of peritoneal dialysis catheter.The patient had the peritoneal dialysis catheter revision and vascular catheter placed on (b)(6) 2015 during the night of (b)(6) 2015, the patient developed atrial fibrillation.She was administered intravenous cardizem and ultimately converted to sinus rhythm on (b)(6) 2015, the patient still complained of shortness of breath patient had decreased breath sounds at the bases.Her vital signs were blood pressure 134/78, spo2 92%, temperature 99.5, heart rate 97, respiration rate 17 chest x-ray confirmed patient had pulmonary vascular congestion.

• 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, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4877455
• MDR Text Key: 15130363
• Report Number: 2937457-2015-01225
• 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,consumer,health prof
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTLR1801
• Device Catalogue Number: LC001759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2009
• 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: CLONIDINE 0.1 MG; VITAMIN D3; VITAMIN B COMPLEX ORAL TABLET; ULTRAM 50 MG ORAL TABLET; THERA M 1 TAB; PERCOCET 10/325 ORAL TABLET; ZOLPIDEM 5 MG; OMEGA-3 POLYSATURATE FATTY ACIDS; MORPHINE 2 MG 1 ML; ATORVASTATIN 10 MG; ALBUMIN HUMAN 25%; XANEX; VITAMIN; SODIUM CHLORIDE 0.9% 10 ML; DEFLEX PD SOLUTION; NS CARRIER FLUID 250 ML; LASIX 80 MG; COREG 3.125; CARDIZEM 120 MG; OXYVODONE-ACETIMINOPHEN 5 MG; PROCRIT 8.000 UNITS; RENVELA 1.600 MG; VANCOMYCIN 1.250 MG; FERROUS SULFATE 325 MG 1 TABS; ZOFRAN; COLACE 200 MG; SODIUM BICARBONATE 850 MG; EPOETIN ALFA 40.000 UNITS/ML
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR