CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpr

FDA device recall Z-1474-2020 · posted 2020-03-18 · Terminated

Recall details

Recalling firm

CME America, LLC

Reason for recall

Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)

Action taken

On 01/07/20, Urgent Medical Device Correction notices were emailed to distributors and mailed to direct customers. For direct customers, Recommendation on further product use included: The recalling firm recommends that customers continue to use the infusion pump system as per intended use. 1. As per standard clinical practice, clinicians administering infusions should assess the fluid container for volumes infused, volumes remaining in the container at the end of the infusion and ensure the total volume of prescribed medication is delivered. 2. Verify your maintenance records to confirm your pump is within one year of the last calibration. Where calibration has not occurred in the last 12 months, please contact your Authorized Service Provider to schedule a calibration as per the current Technical Service Manual. 3. Share this Letter with all users of the product within your facility to ensure awareness and understanding of these actions. The firm remains available for related support and clarification where needed. 4. Complete the attached Customer Response Form Contact Customer/Technical Support at 877-263-0111, Monday thru Friday from 9am to 5pm Mountain Time, for questions regarding this action. Actions Taken by the firm: The calibration instruction has been revised to implement tightened tolerance at plus/minus 1% (refer to Technical Service Manual rev. 10 for OP-12 and rev. 07 for OP-18) Beginning November 26, 2019 the final acceptance testing plan in manufacturing has been revised to include flow rate accuracy performance verification (plus/minus 5%) across the full range (minimum, nominal and maximum flow rates). In addition, distributors were asked to do the following: 1. Place a copy of the Customer Recall Letter in the materials that are distributed to customers with each pump manufactured prior to November 26, 2019. Distributors were asked to email a list of customers who received affected devices to the recalling firm, who wil

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

30,596 pumps

Distribution

U.S.: HI, OR, AR, MA, PA, OH, WY, CO, NE, NC, WA, TX, UT, MD, CA, KY, FL, NH, TN, NY, SD, MO, IL, WI, MN, RI, VA, DC, SC, NJ, ME, KS, CT, MI, LA, AK, NM, IA, MT, ID, AZ, AL, VT, IN, MS

Date initiated

2020-01-07

Date posted

2020-03-18

Date terminated

2022-04-14

Location

Golden, CO

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