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.
What this means for you
Illness, injury, or structural failure has been reported. 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 pharmaceu
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 158
Distribution
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