These safety communications were recently posted by the Food and Drug Administration (FDA):

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console

Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop. Other issues observed by users include the interface going blank, smoke coming from the device, and a burning odor during use. In cases where the pump stopped or the interface went blank, users had to operate the pump using a hand crank until the device restarted or could be replaced by a backup unit. If the pump stops, patients could experience insufficient blood flow potentially leading to organ dysfunction; blood clots potentially leading to low blood pressure; reversible or irreversible neurological dysfunction; or death. More Information.

Alaris Infusion Pumps Serviced by Tenacore

Tenacore is recalling the Alaris Pump because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts may result in free flow of fluids to patient; over delivery or under delivery of fluids delivered to a patient; interruption of fluids delivered to a patient; device leaking; device component burning or smoking; or power supply failure or malfunction. If this device issue occurs, this could cause serious patient harm. More Information.

Alaris Pump Module Model 8100

CareFusion 303 Inc. is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck. This may lead to an infusion delay or interruption, or prevent clinicians from changing fluid or medication infusions on the affected devices. High-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm. For these patients, delays or interruption of infusions can cause serious injury or death. More Information.