Atrium Pneumostat Chest Drain Valve, Part Number 16100

The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

Urgent Medical Device Correction letters dated 3/1/23 were sent to customers. Updated Instructions New Warning and Precautions: The facility can continue use of the product with the IFU that was provided along with the consideration of the following: " NEW and Applicable Existing Warnings and Precautions for Express Mini 500: o NEW Warning: The Express Mini 500 is restricted for use by trained healthcare providers familiar with cardiothoracic surgical procedures and techniques, including the use of chest drains. o NEW Precaution: The Express Mini 500 is restricted for use in a healthcare facility. The Express Mini 500 should not be used for outpatient drainage. o NEW Precaution: Use of the Luer port is intended only for sampling patient drainage. Do not use the Luer port or any other means to empty fluid from the collection chamber. o Existing Precaution: Replace chest drain if damaged or when collection volume meets or exceeds maximum capacity. Actions to be Taken by the Customer: " Please ensure that all Atrium Express Mini 500 Dry Seal Chest Drain users at your facility are aware of this Safety Notice and post a copy of the Notice on Page 3 in all inventory locations within your facility where the devices are stored. Your facility can continue use of the device. No devices need to be returned. " Please forward this information to all current and potential Atrium Express Mini 500 Dry Seal Chest Drain users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Please complete and sign the attached URGENT: MEDICAL DEVICE CORRECTION - RESPONSE FORM on Page 4 to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by emailing a scanned copy of the completed form to [email protected] or or by faxing the form to (866)-308-8040. Type of Action Taken by Getinge: Atrium