There has been a worldwide recall on Alaris Pump modules (model 8100 – formerly known as Medley Pump) by Cardinal Health of Dublin, Ohio. This possibly defective medical device has been associated with serious injuries and possibly two deaths.
The Alaris Pump module may contain occluder springs that are bent, broken, nested or missing altogether due to misassembly during the manufacturing process. The potentially defective products could cause over infusion, which could lead to serious adverse events or death.
At least one injury and two deaths have been associated with these recalled Alaris Pump modules, although the deaths have not yet been categorically linked as the “cause” of death.
Medical professionals and patients are urged not to take any chances and to contact Cardinal Health’s customer service hotline at 1-800-625-6627 as soon as possible if you are affected by this recall, or think you might be. Representatives are available 24-hours a day, seven days a week.
Cardinal health would like to complete an inspection of the device as quickly as possible at their service facility, and will repair units with the misassembled springs. The company is offering site visits and loaners when needed.
In the meantime, Cardinal Health has developed an occluder pressure test (although this should not take the place of a test at their service facility). Learn more about this test here: www.cardinalhealth.com/alaris/indexmodulealert.asp.