On March 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it was recalling CME America’s BodyGuard Infusion Pump Systems over potentially fatal defects. The units affected by the CME pump recall are model numbers:
- BG 323 Pump
- BodyGuard 121 Twins Pump
- BodyGuard 545 ColorVision Pump
- BodyGuard 575 Pump
- CMExpress Pumps
These units were manufactured and distributed from March 06, 2009, to Nov. 29, 2019. CME and the FDA have requested that the 28,448 devices affected by the CME pump recall be returned to them as soon as possible.
As described by the CME pump recall, the devices deliver medication mixed with fluids into a patient’s body to provide a steady and reliable stream of medication. This automatic distribution system has made the device a favorite of hospitals and home care specialists alike.
The CME pump recall highlights one deadly complication in the device’s design. The BodyGuard Infusion Pump System has been reported to the FDA 158 times for inadequate dispersal of medication. The medication’s dispersal can be slower than expected, leading to under-infusion of the medication, or more quickly than predicted, leading to an over-infusion of the medication.
While the CME pump recall states that the reason for these infusion errors is not known, the consequences of over or under-medicating patients are well known. According to the CME pump recall, “the use of the affected infusion pumps may cause serious adverse health consequences including death.” With many medications requiring exact dosages, the average dosing error of 13% could prove fatal.
The FDA has officially recommended that health care professionals not use CME’s devices to administer vasopressors, insulin or any critical medications where infusion accuracy is important. Additionally, all hospitals or distribution facilities that utilize these devices should instead return them to CME with all due haste.
Medical professionals are also called to examine and monitor both the units and the patients using them in order to catch any potential dosage error side effects. Finally, the FDA strongly cautions facilities that intend to allow these devices for home use as errors could be difficult to correct.