Dive Brief:

• Dräger’s breathing system filters recall has been categorized as a Class I event by the Food and Drug Administration after the company reported that a patient had to be resuscitated due to a problem with the device.
• Dräger sent out a safety notice last month in response to one case in which the obstruction of its SafeStar 55 breathing system filter resulted in inadequate oxygen delivery and resuscitation.
• While Dräger expects the human error that led to the distribution of the faulty filter only affected one device, it’s asking customers to return all items from the affected lot for free replacements. According to the FDA, the recall affects 35,950 devices.

Dive Insight:

SafeStar 55 is a mechanical filter designed to protect people from healthcare-associated infections while they are ventilated. Dräger, using a hydrophobic filter membrane of coated glass fibers, has created a set of products intended to stop potentially contaminated fluids such as blood and sputum and reduce the passage of airborne microorganisms. 

Dräger typically performs a 100% resistance test on every filter and automatically destroys any devices that fail the test, the company said in a letter to customers. However, the automatic destruction feature was disabled during servicing, requiring the staff to manually sort the filters based on whether they passed the test.

“During that limited time the filter in question was added to the ‘passed’ box although having failed the resistance test. Our analyses of the supply chain and deliveries indicates that there are most likely no more potentially affected SafeStar 55 in the market – however, it can’t be excluded with absolute certainty,” the company wrote in the letter.

The faulty test that is known to have been distributed while manual sorting was in place was used on a patient during anesthesia. After the filter became obstructed, the patient became hypoxic and had to be resuscitated.

A 2021 adverse event report describes “striking noises” that led the users to disconnect and replace the filter. The patient’s circulatory parameters stabilized after CPR and adrenaline.

If another faulty test made it to customers, ventilation may be restricted, causing oxygen desaturation, the company said.  

Dräger’s existing instructions for use advises users to check components for obstructions, damage and foreign matter before installation. The filters feature both pressure and volume monitoring. Once in use, obstruction should trigger alarms to indicate restricted ventilation, it said. 

Even with those existing safeguards, Dräger is recalling all filters from the affected lot. The company has also “taken measures to ensure that all filters are subject to both resistance test AND automatic sorting and automatic destruction of poor parts respectively,” it wrote in the safety notice to customers.