Reported May 8, 2019 · Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 711 Park Ave · Medina, NY · 14103-1036
Is this the product you have?
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
- product code 35700BAX - Product UsageThe Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the
- following clinically accepted routesintravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive
- Lot codes and dates
158 of 158 codes
414100414670433162710740717215719988720854721951722543722933725642732556734067749265749642749657751266754953755565756625756644758179759427760110760525761003762192763831764008772521772551772633776752777472777487777680777749778181778251778579779966780547780718780817782396782707782811783349783493786411788383788710789338789840790679792271792369794031794748799042
- Amount recalled
- 158
Where it was sold
Why it was recalled
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
This product could cause temporary or reversible health problems — stop using it.
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