Medical Device Correction: Baxter Spectrum Battery Issues

Medical Device Correction: Baxter Spectrum Battery Issues

Baxter Healthcare Corporation is issuing an urgent device correction to the user level for all Spectrum Battery Modules listed on page 2 of this letter, due to customer reports of battery performance issues related to prolonged storage without recharging the battery. The affected battery modules are used with all versions of Spectrum infusion pumps (V6, V8, and IQ).

Recent changes in the market (including implementation delays resulting from the COVID-19 pandemic) have led to prolonged storage of Spectrum Battery Modules. Prolonged storage without recharging may deplete and damage the lithium-ion battery cells, reducing battery capacity and battery run-time. Depletion of the lithium-ion battery cells depends on a number of factors, including the charge level of the battery at the initiation of storage, the temperature at which the battery is stored, and the length of time for which the batteries are stored.

The Spectrum infusion pump will detect depleted batteries following prolonged storage. A depleted battery will not power up on an unplugged Spectrum infusion pump. When the Spectrum pump is plugged in, the pump will alert the user when it detects a depleted battery. When the Spectrum pump is ON and detects a depleted battery, the pump will display a battery error alarm (see Figure 1 below). When the Spectrum pump is OFF (sleep mode) and detects a depleted battery, the pump will display a red-screen battery alert (For Spectrum IQ, see Figure 2 below; for Spectrum V6/V8, see Figure 3 below). If the battery has been damaged due to prolonged storage, the below alarms/alerts will be recurrent, indicating that the battery modules should not be placed into clinical use.

If you have additional questions or experience quality problems, please contact Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

Should you have any questions, please reach out to the US Med-Equip Quality Assurance Team at QA@usmedequip.com .

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