Smiths Medical Update CADD-Solis Li-ion Rechargeable Battery Pack Use Instructions

Today, Smiths Medical’s correction of the CADD-Solis Li-ion rechargeable battery packs was deemed FDA Class I.

The CADD-Solis Li-ion rechargeable battery packs are lithium-ion battery packs used as an alternative power source for its namesake ambulatory infusion pump. The pump is indicated for infusions through intravenous, subcutaneous, intraperitoneal, close to nerves, intraoperative, and the epidural space or subarachnoid spaces. It is used for treatments that require continuous infusion rates, intermittent larger doses, or patient-controlled on-demand doses.

On July 16, Smiths initially contacted users through an Urgent Medical Device Correction letter and notified them of updated instructions for use (IFU). The letter explained that the correction was tied to a potential issue where battery pack damage could lead to a short within the battery that melts the pack casing and stops it from being able to charge. If this were to occur while the battery pack is in use, it may cause burns, injuries related to delays or interruptions in therapy, and death. Currently, there’s been no reported injuries or deaths connected to the issue.

The company is recommending users examine the outside of the battery pack for evidence of damage to the outer case and not use a battery pack that looks to be damaged as per the IFU. The notice also said that a damaged pack should be replaced with either another CADD-Solis rechargeable battery or with four AA batteries. Users are urged to report damaged batteries to the company.

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