—#209040

Product

Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K230041
Affected lot / code info: Pump UDI/DI GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30

Why it was recalled

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/16/2024 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps. If clinicians observe a lack of auto-documentation within the flow sheet or medication administration record, they should verify medication was given, and document in the EMR as if manually programming the pump. The pump will need to be programmed manually rather than through auto-programming for subsequent infusions. 2. A Baxter representative will contact your facility to determine the correction plan and schedule the software upgrade. The representative will work with you to determine a list of affected serial numbers at your facility. Please note you will be receiving this software upgrade from Baxter at no charge. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, d

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US, Nationwide

Timeline

Recall initiated: 2024-07-17
Posted by FDA: 2024-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209040. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.