Cardinal Health has issued an update to its worldwide recall for 201,000 “misassembled” Alaris pump modules, distributed prior to September 27, 2007. Patients using the defective pumps run the risk of over infusion, resulting in serious injury or death.
Subject to the Cardinal Health recall are all model 8100 devices, which were formerly known as Medley pump modules. The pump modules were distributed to 46 states, District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia.
The following is an excerpt from the Cardinal Health press release:
“On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris® Pump modules, model 8100 (formerly known as Medley™ Pump module), shipped prior to Sept. 27, 2007. Serial numbers for affected devices can be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.
The reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion.
The company became aware of the issue from a review of customer complaints and service data. Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device. The deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.”
For additional recall information, or to read the entire press release, see http://www.fda.gov/oc/po/firmrecalls/cardinalhealth12_07.html.
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