Baxter Infusion Pump Recalled for Improper Testing Documentation
Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.
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 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: The source text explicitly states that the defect may result in 'serious adverse health consequences,' which aligns with the Severe (Score 4) criteria for significant injury reports. Although the agency classification is Class II, the potential for serious harm elevates the severity above High.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling 444 units of the Sigma Spectrum Infusion Pump with Master Drug Library (Version 6), part number 35700BAXRP. The recall affects pumps distributed nationwide and in Puerto Rico, specifically those with serial numbers 792177, 795979, 802612, 805938, 807209, 813365, 813367, 871387, 922364, 935968, 962932, and 963087.
The recall was initiated because service technicians improperly documented final release testing. The documentation indicated that the full battery of tests was performed, but several critical tests were actually omitted. These omitted tests include air-in-line detection at flow rates of 400 ml/hr and 800 ml/hr, as well as verification of upstream occlusion detection at 800 ml/hr.
The Baxter Sigma Spectrum Infusion Pump is intended for the controlled administration of fluids, including pharmaceutical drugs, blood, and blood products, via intravenous, arterial, subcutaneous, intrathecal, epidural, or irrigation routes. The device is designed to reduce operator interaction through automated programming.
Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. Consumers who possess these units should contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 444
Distribution
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation 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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