This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. The warning extends to the Sigma Spectrum V6 platform and the Spectrum IQ infusion system with Dose IQ safety software.
Baxter told customers to immediately locate, isolate and case use of all Spectrum pumps with the affected serial numbers.
The company recalled its Spectrum pumps due to the potential for missing motor mounting screws. It says this issue may have occurred during the servicing process for the systems.
Baxter requests the return of affected pumps for inspection and reservicing as applicable. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy or delay in therapy. These outcomes can lead to adverse health consequences. The company reported one serious injury related to the issue.
The company designed its Spectrum infusion pumps for the controlled administration of fluids—including medicine, blood, and blood products—to patients.
