BD Care Coordination Engine Software May Send Outdated Programming Requests
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall designation requires a minimum severity score of Severe (4) per the rubric. No deaths, hospitalizations, or reported illnesses are documented in the source material.
Plain-English summary
The BD Care Coordination Engine (CCE) Infusion Adapter Safety Management Software, manufactured by CareFusion 303, Inc., has been recalled due to a software issue.
The issue may cause outdated automated programming requests (APR) to be sent to the progressive care unit (PCU). This could result in care units receiving and potentially acting on outdated programming instructions.
Affected facilities are located across multiple US states including Arizona, California, DC, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin. The software version affected is v1.7.2, with UDI 10885403510472.
Healthcare facilities using this software should contact the manufacturer for guidance and instructions on addressing this issue.
The recalled product
- Product
- BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- software-error
- stale-data
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software: v1.7.2/UDI: 10885403510472
Distribution
Distributed in 21 states:
- AZ
- CA
- DC
- FL
- GA
- IL
- IN
- MI
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- SC
- TX
- UT
- VA
- WA
- WI
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