If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
Can lead to device failure, possible product contamination, and potential serious adverse health consequences.
Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Risk of injury or death resulting from prolonged interruption in therapy.
Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.
FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Patients may be exposed to serious infections.
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.