The FDA has recognized this as a Class I recall, essentially the most severe sort of recall. Use of those gadgets could trigger severe accidents or dying.
Recalled Product
Product Names: SIGMA Spectrum Infusion Pump with Grasp Drug Library (Model 8) and Spectrum IQ Infusion System with Dose IQ Security Software program (Model 9)
Product Codes: 35700BAX2 and 3570009
Distribution Dates: September 29, 2015 to Might 2, 2023
Units Recalled within the U.S.: 22,769
Date Initiated by Agency: June 15, 2023
Gadget Use
The SIGMA Spectrum Infusion Pump with Grasp Drug Library (Model 8) and Spectrum IQ Infusion System with Dose IQ Security Software program (Model 9) are software-controlled infusion pumps that ship managed quantities of fluids equivalent to pharmaceutical medicine, blood and blood merchandise, and different required therapies. The fluids are offered by way of infusion right into a vein or different cleared route. These infusion pumps are utilized in hospitals and different healthcare services.
Purpose for Recall
Baxter is recalling SIGMA Spectrum Infusion Pumps with Grasp Drug Library (Model 8) and Spectrum IQ Infusion Techniques with Dose IQ Security Software program (Model 9) because of elevated stories of false alarms for upstream occlusion after pump software program upgrades to model v8.01.01 and v9.02.01, respectively.
False upstream occlusion alarms trigger interrupted or delayed remedy and contribute to clinician fatigue, which can trigger severe antagonistic well being penalties, particularly for folks receiving life-sustaining medicines.
Use of those merchandise could result in severe damage or dying.
Baxter stories 131 complaints, three severe accidents, and no deaths associated to this subject.
Who Could also be Affected
Well being care suppliers utilizing SIGMA Spectrum Infusion Pumps with Grasp Drug Library (Model 8) and Spectrum IQ Infusion System with Dose IQ Security Software program.
Sufferers who require care utilizing SIGMA Spectrum Infusion Pumps with Grasp Drug Library (Model 8) and Spectrum IQ Infusion System with Dose IQ Security Software program.
What to Do
On June 15, 2023, Baxter despatched affected prospects an Pressing Medical Gadget Correction letter with the next suggestions associated to pumps with software program model v8.01.01 or v9.02.01:
Proceed to make use of Spectrum V8 and Spectrum IQ pumps by following on-screen directions or infusion setup directions within the Operator’s Guide. Related guide sections embrace: Getting ready the Pump and IV Units Programming the Pump Alarms: Upstream occlusion alarm troubleshooting
Observe that false upstream occlusion alarms can happen at a better charge till a software program reversion is accomplished. In case you are unable to resolve an upstream occlusion alarm, unload and reload the set.
Acknowledge receipt of the notification (even should you would not have any remaining stock) by responding on the Baxter buyer portal at https://BaxterFieldActionCustomerPortal.onprocess.com. Log in to the portal utilizing the account quantity listed within the enclosed reply type instruction sheet.
Ahead a replica of the communication to another services or departments that obtained distributed merchandise.
The letter additionally notes {that a} Baxter consultant will contact services to find out the correction plan and schedule a no cost software program reversion for all affected pumps to the earlier software program model, v8.01.00 or v9.02.00. The consultant will assist services decide an inventory of affected serial numbers.
The software program variations v8.01.01 and v9.02.01, the topic of this recall, have been created to deal with a earlier Class I recall for variations v8.01.00 and v9.02.00 that offered a threat of those pumps not alarming for repeated upstream occlusion occasions.
If the infusion pumps in use have the software program model v8.01.01 or v9.02.01, you must comply with the suggestions listed right here.
If the infusion pumps in use have the software program model v8.01.00 or v9.02.00 (both because of reversion or the software program was not up to date from v8.01.00 or v9.02.00), you must discuss with Baxter’s prior suggestions for the Class I recall surrounding pumps not alarming for repeated upstream occlusion occasions. These suggestions can be discovered on FDA’s web site.
Baxter is working to repair the difficulty repeated upstream occlusion alarm subject current in software program variations v8.01.01 and v9.02.01. Till a repair may be carried out, all suggestions for the related software program variations needs to be adopted.
Contact Info
Prospects with questions on this recall ought to contact their Baxter gross sales consultant or Baxter World Technical Companies at 800-356-3454 (select possibility 3).
Extra Sources
How do I report an issue?
Well being care professionals and customers could report antagonistic reactions or high quality issues they skilled utilizing these gadgets to MedWatch: The FDA Security Info and Hostile Occasion Reporting Program utilizing the web type or name 1-800-332-1088 for extra data on easy methods to mail or fax the shape.
