Avanos—HALYARD 5 Fr Closed Suction Systems for Neonates/Pediatrics: May Be Blocked, Potentially Resulting in Inadequate Suction

November 13, 2019 | Risk Management News

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​​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a November 4, 2019, Urgent Product Advisory Notice letter submitted by an ECRI Institute member hospital, Avanos states that it has received reports that the central lumen of the above products may be completely blocked (approximately 0.045%, based on complaints regarding distributed units) or partially blocked (approximately 0.07%, based on complaints regarding distributed units). This problem may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids from the patient's airway to prevent oxygen desaturation. The blockage would not be visible to the user but can be detected before catheter use by testing the suctioning effectiveness. A CSC blockage can be life-threatening because the CSC would not be able to suction out any fluids that may obstruct the airway or endotracheal (ET) tube. The manufacturer has not confirmed the...

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