PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/

FDA device recall Z-2910-2020 · posted 2020-09-04 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Action taken

On 08/04/20, Urgent Medical Device Recall notices were mailed to Clinical Users: If the PC unit keypad becomes unresponsive or a key gets stuck, clinicians should remove the device from service and send to Biomedical Engineering. If administering a critical medication, continue the infusion until it is safe to replace the PC unit. Cleaning personnel can minimize the potential for fluid ingress during cleaning by 1) not using a cloth that drips, 2) wringing out the cleaning cloth to squeeze out excess fluid, and 3) not spraying fluids directly onto the device. Biomedical Engineering: If an affected PC unit has an unresponsive keypad or stuck key, remove the unit from service and call the recalling firm for information replacement parts. Until 510(k) clearance, the affected PC unit keypad design will continue to be provided for replacement or repair. Inspect all PC unit keypads for bubbling, cracks, damage, layer separations, and holes. Replace the front case keypad if it fails inspection. Return the completed Customer Response Form. Provide a copy of this letter and enclosures to customers who are currently renting affected devices. Firm is currently working on a design change for the PC unit keypad and will notify customers when replacement keypads are available. Additional Information: Customer Advocacy, 888-812-3266, customerfeedback@bd.com; Training Resources www.bd.com/alaris-system-hardware-recall; Recall Support Center, 888-562-6018, SupportCenter@bd.com; Technical Support, 888-812-3229, DL-US-INF-TechSupport@bd.com; Customer Order Management, 1-800-482-4822, GMB-CTS-CustCareInfusion@bd.com On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or received product with impacted parts. Customers were provided with links to the original recall notices and asked to review the information and complete the customer response form.

Root cause

Reprocessing Controls

Status

Open, Classified

Product code

FRN

Quantity affected

28346

Distribution

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

Date initiated

2020-08-04

Date posted

2020-09-04

Location

San Diego, CA

Related 510(k) clearances