Medical device manufacturer, Baxter Healthcare, has issued a medical device correction concerning its EVO IQ Large Volumetric Pump (LVP) [Product Code: ELVP001UKI; Serial Number: All; Software Version: All versions below V01.02.00.04] due to a software error which affects the optional drug modifier feature. The affected devices were distributed between 7 March 2019 and 16 June 2020.

The error occurs when multiple drugs within a care area start with the same first letter and have the same exact drug modifier names. If these conditions exist, when one of these drugs are selected on the pump, the available options displayed within that modifier (concentrations, dose modes etc.) are for multiple drugs, and it is not clear to the user that some of the selections available do not apply to the drug that has been selected. This may lead the user to select a drug set-up or concentration that should not be available for the intended drug.

This software error could lead to a delay in therapy if the clinician is confused by the available options on the display screen and attempts mitigation measures. Additionally, selecting an incorrect concentration or dose mode for the intended medication may result in either excessive or insufficient therapy. Potential risk to the patient resulting from excessive, insufficient, or delay of therapy is dependent on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, patient status and comorbidities. Also, if the incorrect concentration or dose mode is chosen, it may result in the incorrect drug library limits being applied for the selected drug which may not provide the intended safety limits that were set up for that drug. Depending on these factors, the patient may experience serious adverse health consequences. There have been no reports of patient injury or customer complaints related to this issue.

According to the manufacturer, affected users are instructed to take the following actions:

• Operators may continue to safely use the EVO IQ LVP infusion system until the software upgrade is performed.
• If the optional feature of drug modifiers is implemented at the facility, do not set up the same drug modifier for drugs with the same starting letter within the same care area.
• To review the modifiers in a current drug library, generate a Clinical validation report in the Dose IQ software and review each Care Area, and drugs within each Care Area that are using Modifiers.
• If modifiers are used, review the modifier names and associated drug names and determine if same modifier names are used for drug names starting with the same letter. If this condition exists, edit the modifier names to ensure they are unique.
• Follow the Instructions for Use (IFU) section 4.1 and do not operate the pump until the pump settings, including drug/concentration, dose mode, dose rate, and time for each drug are checked and confirmed to be correct.

The manufacturer will be upgrading all pumps to software version V01.02.00.04 or higher to correct this issue.

According to the local supplier, the affected products are distributed in Hong Kong. Currently, there is no customer using the drug modifier feature in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 22 July 2020