Alaris System PC Unit Model 8015 recallZ-2909-2020 · CareFusion 303, Inc. · initiated Aug 4, 2020

Why it was recalled

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.

FDA root cause category: Reprocessing Controls

What the company is doing

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, [email protected]; Training Resources www.bd.com/alaris-system-hardware-recall; Recall Support Center, 888-562-6018, [email protected]; Technical Support, 888-812-3229, [email protected]; Customer Order Management, 1-800-482-4822, [email protected] 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.

Recall details

Recall number

Z-2909-2020

Recall class

Class I (most serious)

Status

Open, Classified

Initiated by the company

Aug 4, 2020

Posted by the FDA

Sep 4, 2020

Recalling firm

CareFusion 303, Inc.

Quantity

313740

Product code

FRN

FDA submissions

K133532

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, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA

Product description

Alaris System PC Unit Model 8015

Other devices under the same FDA submission

4 devices cleared under K133532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris™ Pump Module, Model 8100

  Carefusion 303, Inc. · Pump, infusion
  1 recall2 deaths5,636 reports
• Alaris 8975

  Carefusion 303, Inc. · Infusion safety management software
  169 reports
• Alaris 9601

  Carefusion 303, Inc. · Pump, infusion
  1 recall0 reports
• Alaris™ Syringe Module, Model 8110 8100

  Carefusion 303, Inc. · Pump, infusion
  14 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 85900).

• Z-2910-2020 · Open, Classified
  PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, …