Safety Alert: Covidien Aquaseal Chest Drains
Covidien Aquaseal Chest Drains (Cardinal Health) – Not Appropriate for Neonates or Children.
A NICU reported difficulty managing pneumothoraces when using the Covidien Aquaseal chest drain. Suction continued even when the black suction port was switched “off.â€
Manufacturer Statement
Cardinal Health has issued a Product Advisory Notice on its Sentinel Seal™, Altitude™, Aqua-Seal™, Thora-Seal™ Chest Drainage Units and accessories.
The above listed Cardinal Health Chest Drainage Units and accessories (CDUs) have been updated to clarify the intended target patient population as adults, 18 years and older.
Cardinal Health is working with the NHS to disseminate this information.
Risk
This information was not originally issued as a formal alert and many neonatal and paediatric units continue to be unaware.
As a result, the device continues to be used in NICU and PICU settings, posing a significant patient safety risk.
Immediate Actions Required
- Review local stock and remove these chest drains from neonatal and paediatric areas.
- Inform all relevant staff that the device is not suitable for neonates/children.
- Switch to alternative paediatric appropriate chest drains.
- Report any incidents/near misses via local governance and the MHRA Yellow Card scheme.
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