BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
Recall
- Recall Number
- Z-1231-2025
- Event Number
- 96069
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 23, 2025
- Posted
- February 24, 2025
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
On 01/23/2025, the firm sent via FedEx, 2-day mail and email an "URGENT MEDICAL DEVICE LABELING CORRECTION" Letter to customers informing them that Through an internal review, BD has identified that in the BD Alaris" System User Manual v 12.3.1 (p/n #P00000455), 12.3.2 (p/n# P00000827) and 12.4 (p/n# P00000828), there is an incorrect note on the Pump Module Set Loading instructions. The manuals incorrectly instruct users to leave the safety clamp in the open position when reloading an infusion set. The correct procedure is to leave the safety clamp in the closed position. Following the incorrect note could potentially disable a safety feature that could result in an accidental over-infusion if the roller clamp is left open. Customers are instructed to: 1. Post the Customer Notification on or near the affected systems as a reminder of the incorrect labeling issue until the Manual/Directions for Use (DFU) have been corrected. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form within 14 days, so that BD may acknowledge your receipt of this notification per FDA requirements and prioritize remediation scheduling. Actions BD is taking: 1. BD is in the process of updating the impacted user manuals. 2. BD will send customers follow-up notifications once the update of user manuals is completed. BD expects an updated user manual to be available by April 2025. For Questions or assistance: Contact - North American Regional Complaint Center for Product Complaints and Technical Questions at: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon Fri 8:00am and 5:00pm CT or Email: [email protected] Contact Post Market Quality for Recall Questions at: Email : [email protected] Fax No.: 312-949-0576
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