Safety Alert: Covidien Aquaseal Chest Drains

A NICU reported difficulty managing pneumothoraces when using the Covidien Aquaseal chest drain. Suction continued even when the black suction port was switched “off.”

Manufacturer Statement

Device is designed for adult use only.

Instructions for use now specify:
“Chest Drainage Units (CDUs) are intended for any adult patient… requiring the evacuation and collection of fluid and/or air from the chest cavity.”

Cardinal Health is working with the NHS to disseminate this information.

Risk

This information was not 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 Aquaseal 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.