Medfusion 4000 Syringe Pump May Delay Sending EHR Infusion Start Messages
Smiths Medical's Medfusion 4000 infusion pump software may delay sending infusion start messages to Electronic Health Record systems, potentially affecting infusion programming and clinical documentation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a software defect creating potential risk of harm through delayed EHR messaging affecting infusion programming and documentation. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
Smiths Medical ASD Inc. has recalled 422 units of the Medfusion Model 4000 Syringe Infusion Pump with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming feature. These devices are used in clinical settings for infusion of blood, blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids at precisely controlled rates.
The recalled units were distributed to clinical facilities in Indiana, Texas, and Virginia. A software defect in these devices creates a potential for delays in sending Infusion Start Messages to third-party Electronic Health Record systems, which may affect the pump's infusion auto-programming capability and may affect the completeness of clinical documentation.
Affected devices are identified by Model Number 4000 (Product Codes 4000-0106-00 and 4000-0106-01) and can be verified against the detailed serial number list in FDA Recall Z-0272-2023. Facilities using these devices should consult the FDA recall notice and contact the manufacturer for guidance.
The recalled product
- Product
- Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 422
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 (2)
- Model Number: 4000
- Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962
Distribution
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