Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.
What this means for you
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: The recall involves a risk-of-harm product where the source text states that improper detection 'may result in serious adverse health consequences,' but no specific injuries or illnesses are reported in the text.
Plain-English summary
Baxter Healthcare Corporation is recalling 444 units of the Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6), model 35700BAXR. The recall was initiated because service technicians improperly documented final release testing on the products. The documentation indicated that the full battery of release tests was performed, but in reality, several specific tests were omitted.
The omitted tests include air-in-line detection at 400ml/hr and 800ml/hr, as well as verification of upstream occlusion detection at 800ml/hr. The source text notes that improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. The affected units were distributed nationwide in the US and in Puerto Rico.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the recall notice. The specific serial numbers affected are: 745365, 750241, 750330, 752814, 754975, 757930, 762405, 763117, 764490, 768855, 772652, 773031, 773134, 773520, 774413, 778845, 779430, 779822, 781545, 782706, 782985, 783185, 787001, 793146, 833195, 865842, 883498, 883854, 889556, 889775, 890230, 891398, 891421, 891647, 891689, 901881, 917897, 917963, 919594, 919736, 919837, 921078, 921819, 924734, 928406, 937123, 940345, 940860, 940949, 941786, 944619, 966019, 990542, 996435, 996823, 997156, 998126, 1011229, 1011544, 1014955, and 1027799.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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 drug
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- 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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