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Catalog Number RTLR180111 |
Device Problem
Device Operational Issue (2914)
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Patient Problems
Congestive Heart Failure (1783); Sepsis (2067)
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Event Date 01/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) - a clinical review of this report concluded that any association between the liberty cycler or any fresenius products and the event of hospitalization related to ¿fluid in lungs, congested heart failure and sepsis¿ cannot be determined based on the lack of information provided.Additional information related to the patient¿s history, comorbidities, the adverse events and hospitalization is needed to determine potential causality.Further information has been solicited.The cycler was returned for an evaluation and the failure mode could not be confirmed.The exterior visual inspection showed no signs of physical damage.A simulated treatment was performed in which the amount of fluid delivered to a pseudo patient bag during each fill phase was weighed.The weighed fluid volumes were compared against the programmed fill value, and the weighed volumes for each fill phase were determined to be within expected tolerance for the liberty cycler.The valve actuation test passed.The system air leak test passed.The patient sensor calibration check passed.The load cell value and verification was within tolerance.There were no internal, visual discrepancies found in the inspection of the received cycler unit.Additionally, 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 history record review confirmed the labeling, material, and process controls were within specification.
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Event Description
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A peritoneal dialysis (pd) patient's mother, called to report that on (b)(6) 2017 the patient completed treatment but when he woke up the following morning, he found that the heater bag was completely empty, the supply bag was so full it looked like it was going to burst and the cassette was puffed out and full of fluid.According to the patient's mother, the patient was admitted to the intensive care unit (icu) with fluid in his lungs, congestive heart failure, and sepsis.However, the patient's renal replacement therapy continued in the hospital by means of manual pd.It appears the patient was discharged from the hospital at some point of time prior to (b)(6) 2017 as the patient was at the clinic during a follow up call to the clinic on that date.Further information has been solicited.No additional information was/has been provided by the clinic.
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Search Alerts/Recalls
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