MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Edema (1820); Heart Failure (2206)

Event Date 01/25/2017

Event Type  Death  

Manufacturer Narrative

(b)(4) - the device was not returned to the manufacturer for physical evaluation, and the failure mode cannot be confirmed.A device serial number was not available.As such a formal device history record (dhr) review could not be conducted.However, a cycler is not released unless all manufacturing and quality criteria are complete.Although a temporal relationship exist between the last continuous cyclic peritoneal dialysis (ccpd) treatment and the cardiopulmonary arrest and subsequent expiration, there is no documentation supporting a possible association between the liberty cycler and the patient's expiration.Prior to that event, and during the hospitalization, the patient successfully performed dialysis treatments with fresenius products without issues; the patient had been on peritoneal dialysis since (b)(6) 2016.The patient¿s had a significant and complex medical history, including coronary artery disease, peripheral artery disease and diabetes, heart failure, ejection fraction 35%; nstemi (non-st elevated myocardial infarction) diabetes mellitus and an aicd.The arrhythmias and cardiac arrest were the ultimate cause of death.There were no allegations against the liberty cycler or any of the fresenius products.

Event Description

It was reported by an inpatient educator at the patient's clinic that the patient coded while connected to the facility cycler and subsequently expired.The patient was reportedly approximately half way through their treatment.It was later reported in received medical records that the patient initially presented to the emergency room with left leg swelling, noted redness of their foot with an onset of one week prior to the hospitalization, and elevated cardiac enzymes.On (b)(6) 2017, at 00:17, and approximately half way through the cycler dialysis treatment, the patient became unresponsive with cardiopulmonary arrest.Initially the patient had a pulse via doppler, but no palpable pulse, and was apneic.Cardiopulmonary resuscitation was initiated, the patient was intubated, and the patient received routine advance life support measures, including multiple doses of epinephrine, atropine, bicarbonate, calcium, dopamine, and epinephrine drip.The patient¿s cardiac rhythm was agonal versus coarse ventricular fibrillation and the patient was defibrillated.The resuscitation efforts continued unsuccessfully for 45 minutes, at which point the patient was pronounced deceased at 01:00.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6347663
• MDR Text Key: 67905109
• Report Number: 2937457-2017-00117
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/25/2017
• 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: AMIODARONE; ASPIRIN; ATORVASTATIN; CALCIUM ACETATE; CINACALCET; COLCHICINE; COUMADIN; INSULIN NPH; LIBERTY CYCLER CASSETTE; METOPROLOL; MIDODRINE; NITROGLYCERINE; PANTOPRAZOLE; PD FLUID; RANOLAZINE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 129