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Catalog Number RTLR180111 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Heart Failure (2206)
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Event Date 03/15/2017 |
Event Type
Death
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Manufacturer Narrative
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(b)(4) - the clinical evaluation determined that although a temporal relationship exist between the last ccpd treatment and the patient subsequent expiration, there is not enough information to consider potential causality.Prior to the event the patient had progressive increase of blood pressure and significant decrease of ultra filtration.This possibly contributed to the patient expiration.Additionally the patient's significant and highly complex comorbidities; including diabetes mellitus, hypertension, hyperphosphatemia and hypokalemia 3 put the patient at high risk for sudden death.The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.
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Event Description
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On 03/17/2017, it was reported by the peritoneal dialysis registered nurse (pdrn), that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy since (b)(6) 2017 expired on (b)(6) 2017 while connected to the liberty cycler, it appeared that the patient completed the ccpd treatment.A spontaneous fatal event of heart failure was attributed as the cause.Treatment records prior to the event showed an upward trend in the patient¿s blood pressure and a downward trend in the patient¿s pd ultrafiltration values.Esrd death notification was made available by the pdrn, which listed the primary cause of death as ¿cardiac arrest, cause unknown¿ with no secondary causes.Esrd death notification was made available by the pdrn, which lists the primary cause of death as ¿cardiac arrest, cause unknown¿ with no secondary causes.
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Search Alerts/Recalls
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