On July 18, 2019, 151 Million Alaris 8100 infusion sets were RECALLED by Becton Dickinson due to a silicon tube defect that caused Overdoses of dangerous medications that resulted in severe injury and death. (This device had been marketed as Carefusion)
Manufacturer wrote to hospitals in its recall:
"This recall has been associated with MDR reports, several of which are associated with serious injuries." Medical Device Reports or MDR are made by doctors and hospital to the FDA.
Becton Dickinson manufactured and then distributed around the world 151 million life threatening defective silicon tubes without noticing. What a quality control disaster!!!
In this design the pump pinches or occludes the silicone tube to stop the flow of dangerous medication to the patient. This admitted defect in the tube allowed the medicine to continue to be pumped into the patient even though the electronic monitor told nurses and doctors that no medicine was being infused, in what is termed a "free flow" that resulted in an over infusion. This outdated pump DOES NOT measure, either mechanically or electronically, the actual amount of medicine pumped into the patient!!!! The pump assumes delivery of the programed amount by a mathematical calculation therefore nurses and doctors have no way of knowing what went into their patient because the pump will report everything had been delivered correctly.
If you or a loved one has been injured by a free flow resulting in an overinfusion contact us as soon as possible. The machine and the tubing must be maintained for testing to prove your injury. Time if of the essence. Please call or text Tamara Segal at 972-757-1717. You can email either of us at or Tamara@brocklawpllc.net . This consultation is free.
www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-recalls-alaris-infusion-sets-alaris-pump-model-8100-due-potential-tube-collapse
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