Sigma Spectrum infusion pumps FDA alert and clinical advice

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FDA report “Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy.

If the System 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual “322” alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.”

Other intravenous and vascular access resources that may be of interest (External links – IVTEAM has no responsibility for content).

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