# FDA 483 - CareFusion 303, Inc. - April 06, 2020

Source: https://www.keypedia.com/records/483/carefusion-303-inc/f7ef7fac-ae70-4f01-8c52-6cfc2245a331

> FDA 483 for CareFusion 303, Inc. on April 06, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CareFusion 303, Inc.
- Inspection Date: 2020-04-06
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: The FDA inspected CareFusion 303, Inc., a medical device manufacturer in San Diego, CA, from March 2 to April 6, 2020. The inspection revealed eight observations regarding their quality system and manufacturing processes for medical devices, including the Alaris Infusion system.

Key observations include:
1.  **Inadequate Corrective and Preventive Action (CAPA) Procedures:** A CAPA (CA-2018-0161) initiated for inter-unit interface (IUI) connector failures due to corrosion/contamination, which can interrupt communication or power to infusion modules, had a risk assessment that concluded "extremely low" patient harm probability. This conclusion failed to consider a complaint (MDR #2016493-2015-00154) where a communication failure contributed to a patient's death.
2.  **Inadequate Complaint Handling Procedures:** Between June 2018 and March 2020, 47,951 Alaris Infusion system complaints lacked documentation of Medical Device Report (MDR) reportability determination. This includes 39 complaints of over/under infusion.
3.  **Incomplete Device Software Validation:** The software development procedure lacks a requirement for testing according to reviewed and approved test cases. Additionally, the issue tracking system is used for non-software related issues without established procedures for timely investigation and effective corrective

## Related Documents

- [483 - 2018-09-06](https://www.keypedia.com/records/483/carefusion-303-inc/2b146def-bcb7-4763-bebb-47a0f2ecc22d)
- [483 - 2020-04-06](https://www.keypedia.com/records/483/carefusion-303-inc/6fb77e5f-514f-4201-a4d9-a5cc5866ed99)
- [483 - 2024-05-22](https://www.keypedia.com/records/483/carefusion-303-inc/9ca517a6-d26a-4185-849d-83053b2efdd3)

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/carefusion-303-inc/e44e5a89-d532-4564-ac5f-1aff2b7d8974

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b