Agency classClass IIOur severity:Severe FDA (Devices)·Z-1248-2019·Announced 2019-05-08

Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

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 device defect could lead to 'serious adverse health consequences' due to over- or under-infusion, which aligns with the rubric criteria for a Severe (Score 4) recall involving significant injury reports or potential for serious harm.

Plain-English summary

Baxter Healthcare Corporation is recalling 158 units of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX. The recall was initiated because the flow rate test verification was not properly executed for these specific pumps prior to release. The testing was performed for less than the required minimum run time.

Improperly performed flow rate testing may fail to identify issues with the pumps that could cause inaccuracies in flow rates. These inaccuracies could lead to over-infusion or under-infusion of fluids, which may include pharmaceutical drugs, blood, or blood products. The potential risk to the patient depends on factors such as the specific treatment and patient comorbidities, and could result in serious adverse health consequences.

The affected units were distributed nationwide in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI. Healthcare facilities should check their inventory for the specific product code and serial numbers listed in the recall notice and contact Baxter Healthcare for instructions on how to return or replace the devices.

The recalled product

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - 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 include…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: over-infusion
under-infusion
inaccurate-flow-rate
Affected units: 158

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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