Edwards Lifesciences LLC, FCA-168, HEMFSM10 - Fore-Sight Elite Tissue Oximeter Module
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module (Model HEMFSM10) or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (Model 01- 06-3000) with the Fore-Sight Elite large sensor (FSESL) in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change.
Adult cerebral and flank/abdomen locations using the large sensor are not impacted. Measurements made during pediatric and pediatric neonatal monitoring with small and medium sensor sizes are not impacted.
Low StO2 values may lead to unintended or inappropriate treatment. The low StO2 values are noticeable upon start-up when using the large sensors. This will allow the clinician to assess the patient’s clinical condition prior to performing any additional treatment. The system will alarm if the values are outside of the set physiological range.
Edwards has received three (3) internal complaints related to this issue.
Customers are to refrain from using the large sensors on certain somatic locations (arms and legs). Cerebral and flank/abdomen locations for the large sensors are not impacted.
Fabrikant: Edwards Lifesciences LLC
Product: HEMFSM10 - Fore-Sight Elite Tissue Oximeter Module (FSM) (smart cable) + 01-06-3000 - FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor.
Datum FSN: (documentdatum) 25-02-2022
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