ParaPAC Plus Ventilator Recall Issued Due to Risk of Serious Injury or Death

Smiths Medical indicates paraPAC plus ventilators may have loose or detached patient outlet connectors, which have already resulted in one fatality.

An urgent medical device notification has been issued regarding problems with paraPAC plus ventilators, due to a risk that loosened or detached outlet connectors could cause patients to experience reductions in ventilation therapy, which may result in serious and life-threatening injuries.

ParaPAC plus ventilators are gas-powered emergency ventilators intended to provide ventilator support for adults, children and infants in emergency situations and during transfers between hospitals or within medical facilities. The ventilators provide free flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients, such as during CPR resuscitation.

The U.S. Food and Drug Administration (FDA) posted information about the paraPAC plus ventilator recall on September 20, warning about the risk of severe problems that could occur if the patient outlet connector becomes loose or detached. Patient outlet connectors are necessary tubing parts that connect the ventilator to the patient. Their damage may lead to not enough ventilation (hypoventilation), not enough oxygen (hypoxia), slowed heartbeat (bradycardia), low blood pressure (hypotension), respiratory arrest or death.

The manufacturer, Smiths Medical, first sent a letter (PDF) to affected customers on May 31, indicating that they had received reports involving at least one death and one injury linked to problems with the emergency ventilators.

ParaPAC Plus Models Affected by Smiths Medical Ventilator Recall

The warning impacts all models of PneuPAC paraPAC plus P300 and P310 ventilators, including paraPAC plusTM plus kits without internal PEEP & CPAP, list number P300NXX, as well as paraPAC plusTM kits with internal PEEP & CPAP, list number P310NXX.

As a result of the product defects, Smiths Medical is urging all customers who have a recalled ventilator to inspect the patient outlet connector and to remove the ventilator from use if the connector is loose or moves. Affected ventilators should be reported so they can be repaired by Smiths Medical.

If the outlet connector remains tight after a visual and physical inspection, customers should maintain heightened awareness and follow all pre-use checks as per the user manual.

If the paraPAC plus outlet connector becomes detached, a low pressure or disconnect alarm may be triggered on the device, due to oxygen no longer moving through the device’s patient tubes properly. This problem could be indicated to users or staff by the device’s manometer needle not moving. Manometer needles measure pressure in the ventilator tubes that connect the device to the patient. Even though the device may register the issue at the time of pressure failure, inspections and pre-checks should still be conducted to ensure devices are working properly before use.

This warning from Smiths Medical is separate from the Bivona Tracheostomy Tube recall issued by the company earlier this year.

Affected paraPAC plus devices should be reported to Smiths Medical via email at globalcomplaints@icumed.com.

Customers are asked to complete and return the customer response form included with the letter to smithsmedical5253@sedgwick.com within ten days of receipt.

For questions about the recall, customers can contact Smiths Medical Technical Support at 1-800-241-4002, option 3.

Adverse reactions or quality issues can be reported directly to Medwatch, the FDA’s safety information and adverse event report program.