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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
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.
 
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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 Key6347663
MDR Text Key67905109
Report Number2937457-2017-00117
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123630
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Device Operator Other Health Care Professional
Device Catalogue NumberRTLR180111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 01/25/2017
Initial Date FDA Received02/21/2017
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 Number1
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 Age65 YR
Patient Weight129
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