BD Care Coordination Engine Software May Send Outdated Programming Requests
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units.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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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The issue may cause outdated automated programming requests (APR) to be sent to the progressive care unit (PCU). This could result in care units receiving and potentially acting on outdated programming instructions.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
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
Part of a larger recall action
This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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