Recalls / —

—#182588

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K133801

Affected lot / code info

Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570

Why it was recalled

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Root cause (FDA determination)

Labeling design

Action the firm took

A Safety Alert communication was sent to affected customers on 04/01/2020 via USPS First Class Mail. A follow-up Urgent Device Correction communication was sent to all affected customers on 8/28/2020 via USPS first class mail. The customer communications reiterate instructions for use listed in the Operator's Manual. Baxter is asking customers to: 1) Operators may continue to safely use the infusion pumps while following the instructions for cleaning provided in the Operator's Manual. An electronic copy of the Operator's Manual can be accessed at https://service.baxter.com. In addition, a full list of approved cleaning agents can be accessed at www.spectrumIQ.com/resources.html. 2) Inspect all pumps at their facility to assess the electrical pins on the pump rear case and the battery electrical contacts for residue buildup or corrosion. If corrosion or residue buildup is identified, please contact Baxter to service the device. 3) Baxter will be updating the Instructions for Use to recommend a routine inspection process for the electrical pins on the pump rear case and the battery electrical contacts. Once the updated Instructions for Use are made available, Baxter will issue a written notification to inform customers of the availability of the updated IFU. The updated IFU may be accessed online at the Baxter Global Technical E Service Center at URL: https://service.baxter.com. 4) Clinicians should ensure backup devices are readily available when infusing critical medications where interruptions could cause serious injury or death. 5) To maintain the battery properly, please ensure the pumps are plugged into AC power when possible to prevent battery depletion. 6) Complete the enclosed customer reply form and return it to Baxter by email. On 9/22/2021, the firm issued an Urgent Device Correction letter dated 9/22/2021 in follow-up to their communication of the 4/1/2020 safety alert and 8/28/2020 Urgent Device Correction. This was issued via first class USPS ma

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

Timeline

Recall initiated

2020-06-30

Posted by FDA

2020-10-22

Terminated

2024-04-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #182588. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.