The FDA recently labeled Smiths Medical’s recall of some ventilators as Class I, the most serious kind.
ICU Medical’s Smiths Medical initiated a recall of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits on February 7. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath when switched to the “Ventilate” operating mode. Smiths Medical labeled this a malfunction that could prevent the ventilator from functioning properly.
Patients may not receive the right amount of ventilation or enough oxygen when using certain models of PneuPac paraPAC Plus 300 and 310 Ventilator kits. It may also cause a complete or partial airway obstruction. There is potential for serious injury or death related to this recall, according to the FDA warning letter.
Smiths Medical said 2,906 devices distributed between January 1, 2013, and September 11, 2023, may be affected by this recall. The full database of affected devices can be found in the FDA warning letter here.
There have been 177 MDR events reported, of which 8 were serious injuries related to the issue. There have been no reports of death.
What are the PneuPac paraPAC Plus 300 and 310 Ventilator kits?
The ventilator kits involved in the recall are gas-powered emergency and transport portable ventilators that can be used in vehicles such as airplanes and helicopters. They can be used in emergencies at an accident scene and in transport between hospitals or within a hospital or medical facility.
PneuPac paraPAC Plus 300 and 310 Ventilator kits are intended for use in the ventilatory support for adults, children and infants above approximately 10 kg in weight.
The paraPAC Plus devices also provide free-flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients. They can be used in emergencies to provide ventilatory support for CPR resuscitation.
Smiths Medical recommends that ParaPAC Plus ventilators only be used under the constant supervision of trained healthcare professionals.
How Smiths Medical is fixing the problem
Smiths Medical sent an urgent medical device correction notice to customers who may be affected by this recall. It recommended there is no need to return or discontinue using paraPAC at the time as the recall is a correction and not a product removal.
When operating the device, the company said strict adherence to all instructions provided in the user manual is important. This includes paying close attention to warnings and cautions, including continuous monitoring of the patient, independent monitoring of blood oxygenation and expired carbon dioxide levels using pulse oximetry and capnography, conducting all required pre-use checks before each use, ensuring the availability of alternative ventilation methods such as bag-mask ventilation in case of ventilator malfunction or failure, and promptly discontinuing use and arranging for repair if the paraPac plus ventilator experiences continuous flow issues, while resorting to another device or alternative means of ventilation in the meantime.
The company also recommended healthcare providers identify all paraPAC Plus units in possession and complete and return the customer response form to Smiths Medical.
