Baxter SIGMA Spectrum Infusion Pump with Master Drug… recallZ-0530-2022 · Baxter Healthcare Corporation · initiated Dec 29, 2021

Why it was recalled

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

FDA root cause category: Device Design

What the company is doing

The firm sent URGENT SAFETY COMMUNICATION letters on 12/29/2021 via first class mail, addressed to Directors of Biomedical Engineering, Risk Management, Nursing, and Nurse Educators. The letter described the problem, the affected product (Spectrum V8 and Spectrum IQ infusion pumps), hazard involved, and the actions to be taken by customers. Acknowledge receipt on customer portal https://BaxterFieldActionCustomerPortal.onprocess.com/. Follow on-screen instructions, infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections, and upstream occlusion alarm troubleshooting in the Alarms section of the Operator's Manual. Upon an upstream occlusion alarm, do not press the RUN/STOP key prior to inspecting the IV tubing and resolving any occlusions. If an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally, and may be infusing below the programmed rate or not at all. If you may have resumed an infusion without clearing an occlusion, stop the infusion: press the RUN/STOP key, clear the occlusion, and restart the infusion. Per the IFU: It is important to completely spike the IV container, remove the blue slide clamp completely from the keyhole, disengage the blue slide clamp completely from the IV tubing, check that the IV tubing is clear of any kinks or collapsed sections, ensure the roller clamp is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting the infusion, verify that drips are flowing in the drip chamber. If an upstream occlusion is not fully cleared above the pump and/or within the pumping channel, an upstream occlusion alarm may not reoccur. **On 1/19/2022, the firm reported they plan to issue a follow-up communication approximately March 2022 to customers once the IFU has been updated and will include information regarding upcoming software updates. The firm sent a follow-up URGENT DEVICE CORRECT

Recall details

Recall number

Z-0530-2022

Status

Open, Classified

Initiated by the company

Dec 29, 2021

Posted by the FDA

Jan 29, 2022

Recalling firm

Baxter Healthcare Corporation

Quantity

146,502 units

Product code

FRN

FDA submissions

K133801

Distribution

Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.

Product description

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• SIGMA Spectrum Infusion Pump 35700BAX2

  Baxter Healthcare Corporation · Infusion safety management software
  9 recalls12 deaths11,585 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89017).

• Z-0529-2022 · Open, Classified
  Baxter Spectrum IQ Infusion Pumps, Product code 3570009.