RT’s Three Key Takeaways:
- Smiths Medical is recalling PneuPAC paraPAC Plus P300 and P310 ventilators as a result of threat of the affected person outlet connector loosening or detaching, which may interrupt air flow.
- The FDA has labeled this as a Class I recall, essentially the most severe kind, warning of potential life-threatening well being penalties, together with hypoxia and respiratory arrest.
- Affected healthcare suppliers are urged to examine all gadgets instantly, with any unfastened connectors requiring elimination for restore to keep away from potential failures throughout affected person use.
Smiths Medical is recalling paraPAC plus P300 and P310 ventilators as a result of chance that the affected person outlet connector might loosen or detach, which can impression lively air flow.
If the affected person outlet connector is loosened or indifferent it may trigger prolonged interruption of remedy, no air flow, delay of remedy, and lowered tidal quantity.
The usage of the affected product might trigger severe hostile well being penalties, together with hypoventilation, hypoxia, bradycardia, hypotension, respiratory arrest, and loss of life. The US Meals and Drug Administration has recognized this recall as essentially the most severe kind. There was one reported damage and one report of loss of life.
[RELATED: Smiths Medical Recalls PneuPac paraPAC Plus Ventilator Kits]
Smiths Medical PneuPAC paraPAC Plus P300 and P310 ventilators are gas-powered emergency and transport moveable ventilators, together with in automobiles equivalent to airplanes and helicopters. They’re appropriate for emergency use at accident scenes and transports between hospitals or inside a hospital or medical facility. These ventilators are meant to offer ventilatory assist for adults, youngsters, and infants.
The paraPAC Plus gadgets additionally present free-flow oxygen remedy and steady constructive airway strain remedy for spontaneously respiration sufferers. The gadgets will also be utilized in emergency conditions to offer ventilatory assist for CPR resuscitation.
ParaPAC Plus ventilators ought to solely be used underneath the fixed supervision of educated well being care professionals.
This recall entails eradicating sure gadgets from the place they’re used or offered.
Affected product:
- Product names: PneuPAC paraPAC Plus P300 and P310 Ventilators
- Distinctive system identifier (UDI)/Record Quantity: /P300NXX*, / P310NXX*
- Mannequin numbers: All fashions are affected.
What to Do
On Could 31, Smiths Medical despatched all affected prospects an Pressing Medical Gadget Correction letter recommending the next actions:
- Examine all probably affected paraPAC plus models to find out if gadgets are affected:
- Carry out a visible inspection to find out if the outlet connector is disconnected.
- Consider the connector bodily to find out if the outlet connector is unfastened or strikes when inserting a affected person circuit on the connector or when eradicating it.
- Take away any system the place the outlet connector strikes or feels unfastened so it may be repaired by Smiths Medical.
- Report eliminated gadgets to International Criticism Administration at [email protected].
- Proceed to make use of gadgets if the outlet connector stays tight after bodily inspection, sustaining heightened consciousness and following all pre-use checks as per the person handbook.
- Pre-checks should be accomplished as described within the person handbook for each use after inspection.
- Take additional warning to examine the outlet connector prior to every use, earlier than inserting the affected person circuit on the connector, and through elimination.
- Be sure you observe all directions together with warnings and cautions within the UserManual Doc. numbers (10018833-003 and/or 10026347-002) when utilizing these gadgets, together with:
- All pre-use checks should be carried out earlier than every use.
- Fixed affected person monitoring.
- Monitor blood oxygenation and finish tidal carbon dioxide ranges independently with pulse oximetry and capnography.
- Have alternate technique of air flow, equivalent to bag masks air flow, accessible in case of ventilator failure or malfunction.
- The next design mitigation and alarms could also be triggered by this situation:
- Low Stress/Disconnect alarm
- Stress Monitor: Disconnection/detachment of the affected person outlet connector can be indicated by no motion of the manometer needle.
- Share this recall notification with all potential customers of the gadgets to make sure they’re conscious of the difficulty and proposed mitigations.
- Full and return the shopper response kind included with the letter to [email protected] inside 10 days of receipt.
- Distributors: Instantly ahead this discover to any buyer who might have obtained these gadgets from you. Request that they full the response kind and return it to [email protected].