CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets – FDA.gov

Summary Company Announcement Date: April 27, 2020 FDA Publish Date: April 29, 2020 Product Type: Medical Devices Reason for Announcement:

Recall Reason Description

pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids

Product Description

Infusion pumps and infusion sets

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020).

Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard infusion pump system and to remove all existing products from the U.S. market. The following is a summary of each individual product recall details:

CMEAmerica BodyGuard Infusion Pump Recall Details

On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall.

CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic:

The BodyGuard infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard infusion pumps listed below. These devices are primarily used in outpatient settings.

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard Microset Infusion Set Recall Details

On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard Microset infusion sets, when used with the BodyGuard infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers.

To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers.

Affected products include:

Customer inquiries related to either recall, as well as adverse reaction/events experienced with the product should be addressed to CME America Support Center at 877-263-0111.

FDA MedWatch Reporting

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.

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CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets - FDA.gov