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Catalog Number RTLR180111 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiopulmonary Arrest (1765); Death (1802); Edema (1820); Heart Failure (2206)
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Event Date 01/25/2017 |
Event Type
Death
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Manufacturer Narrative
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(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.
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Event Description
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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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Search Alerts/Recalls
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